Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
This study is currently recruiting participants.
Verified March 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00408005
First received: December 4, 2006
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Contiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Stage II Adult T-cell Leukemia/Lymphoma Stage II Childhood Lymphoblastic Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Adult T-cell Leukemia/Lymphoma Stage III Childhood Lymphoblastic Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Adult T-cell Leukemia/Lymphoma Stage IV Childhood Lymphoblastic Lymphoma T-cell Adult Acute Lymphoblastic Leukemia T-cell Childhood Acute Lymphoblastic Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia |
Drug: doxorubicin hydrochloride Drug: cytarabine Drug: daunorubicin hydrochloride Drug: prednisone Drug: pegaspargase Drug: methotrexate Drug: leucovorin calcium Drug: cyclophosphamide Drug: mercaptopurine Drug: nelarabine Drug: asparaginase Drug: dexamethasone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy Other: laboratory biomarker analysis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intensified Methotrexate, Nelarabine (Compound 506U78; IND #52611) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Prednisone
Methotrexate
Cytarabine
Thioguanine
Calcium Gluconate
Dexamethasone acetate
Leucovorin calcium
Vincristine sulfate
Dexamethasone sodium phosphate
Asparaginase
Sulfate ion
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Levoleucovorin
Nelarabine
Pegaspargase
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival (EFS) after initial remission [ Time Frame: At 4 years ] [ Designated as safety issue: No ]This outcome can be modeled reasonably well by a linear decreasing hazard rate with no appreciable risk of failure after completion of year 4. EFS events include any type of relapse, death in remission or second malignant neoplasm. "Intent-to-treat" analyses (i.e. based on the regimen to which patients are initially randomized) will be the primary approach used to assess treatment efficacy.
- Nelarabine toxicity assessment by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: From week 6 to up to week 43 ] [ Designated as safety issue: Yes ]Compared directly to their randomized control not receiving nelarabine with additional examination of the comparison within the separate methotrexate regimen subsets. These comparisons will focus on grade 3 or higher non-hematologic toxicities. The overall incidence of selected neurologic toxicities will also be monitored since these represent an important target category for nelarabine toxicity.
- Safety of combination chemotherapy with vs without nelarabine as assessed by NCI CTCAE version 4.0 [ Time Frame: From week 6 to week 43 ] [ Designated as safety issue: Yes ]Futility testing boundaries will be used for the comparison of "Nelarabine" versus "No Nelarabine" to decide if stopping should occur for similarity of outcome. This will be tested with a Pampallona-Tsiatis type lower monitoring boundary when approximately 20%, 40%, 60% and 80% of the EFS event information is available.
- Efficacy of combination chemotherapy with vs without nelarabine [ Time Frame: Assessed up to 10 years ] [ Designated as safety issue: Yes ]"Intent-to-treat" analyses (i.e. based on the regimen to which patients are initially randomized) will be the primary approach used to assess treatment efficacy.
- Safety and efficacy of high-dose methotrexate (with leucovorin calcium rescue) and mercaptopurine vs escalating-dose methotrexate (without leucovorin calcium rescue) and pegaspargase [ Time Frame: At each dose level of treatment ] [ Designated as safety issue: Yes ]Analyses will be performed regularly to assess the possibility of an interaction effect (using a Cox regression likelihood ratio test) which will assess the four individual treatment regimens in the 2 x 2 design to see if a non-proportional hazards effect occurs for the combinations of the two main effect factors. Since the comparison of the methotrexate regimens utilizes a selection type analysis, no futility testing will be used for that comparison.
| Estimated Enrollment: | 1580 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (Consolidation chemotherapy)
Patients receive methotrexate (MTX) intrathecally (IT) on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43 and 50; and pegaspargase intramuscularly (IM) or IV over 1-2 hours on days 15 and 43. Patients with Down syndrome (DS) also receive oral leucovorin calcium at 48 and 60 hours after each MTX dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic cranial radiotherapy (CRT) (1,200 cGy/dose) once daily on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT.
|
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cytarabine
Given IT, IV, or SC
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: leucovorin calcium
Given orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Radiation: radiation therapy
Some patients undergo testicular and/or prophylactic cranial RT
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm II (Consolidation chemotherapy)
Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; MTX IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV or SC on days 8-11, 15-18, 50-53 and 57-60; oral mercaptopurine on days 8-21 and 50-63; vincristine IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT once daily on days 22-28 and 29-35.
|
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cytarabine
Given IT, IV, or SC
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: leucovorin calcium
Given orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: nelarabine
Given IV
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Radiation: radiation therapy
Some patients undergo testicular and/or prophylactic cranial RT
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm III (Consolidation chemotherapy)
Patients receive MTX, cyclophosphamide, cytarabine, mercaptopurine, vincristine, and pegaspargase as in arm I. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy as in arm I (DS patients excluded as of 09/29/10).
|
Drug: cytarabine
Given IT, IV, or SC
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm IV (Consolidation chemotherapy)
Patients receive nelarabine, MTX, cyclophosphamide, cytarabine, mercaptopurine, vincristine, and pegaspargase as in arm II. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy as in arm II (DS patients excluded as of 09/29/10).
|
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: nelarabine
Given IV
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm I (Interim maintenance chemotherapy)
Patients receive vincristine IV and escalating doses of MTX IV on days 1, 11, 21, 31, and 41; pegaspargase* IM or IV over 1-2 hours on days 2 and 22; and MTX IT on days 1 and 31. Patients with DS also receive oral leucovorin calcium 48 and 60 hours after each MTX IT dose (DS patients excluded as of 09/29/10). Note: *Patients with an allergy to pegaspargase receive Erwinia asparaginase on days 2, 4, 6, 8, 10, 12, 22, 24, 26, 28, 30, and 32.] |
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: leucovorin calcium
Given orally
Other Names:
Drug: asparaginase
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm II (Interim maintenance chemotherapy)
Patients receive vincristine, escalating doses of MTX, pegaspargase, and MTX IT as in arm I.
|
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: leucovorin calcium
Given orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm III (Interim maintenance chemotherapy)
Patients receive high-dose methotrexate (HDMTX) IV over 24 hours and vincristine IV on days 1, 15, 29, and 43; oral mercaptopurine on days 1-56; and MTX IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or orally once every 6 hours for 3 doses.
|
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: leucovorin calcium
Given orally
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm IV (Interim maintenance chemotherapy)
Patients receive HDMTX, vincristine, mercaptopurine, MTX IT, and leucovorin calcium as in arm III.
|
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: leucovorin calcium
Given orally
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm I (Delayed intensification chemotherapy)
Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone IV or orally twice daily on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients ≥ 10 years of age and for patients with DS); doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; MTX IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or SC on days 29-32 and 36-39; and oral thioguanine on days 29-42. Patients with DS also receive oral leucovorin calcium at 48 and 60 hours after each MTX dose (DS patients excluded as of 09/29/10).
|
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cytarabine
Given IT, IV, or SC
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: leucovorin calcium
Given orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm II (Delayed intensification chemotherapy)
Patients receive vincristine IV on days 1, 8, 15, and 50; dexamethasone IV or orally twice daily on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients ≥ 10 years of age); doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; MTX IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV or SC on days 36-39 and 43-46; and oral thioguanine on days 36-49.
|
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cytarabine
Given IT, IV, or SC
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: nelarabine
Given IV
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm III (Delayed intensification chemotherapy)
Patients receive vincristine, dexamethasone, doxorubicin hydrochloride, pegaspargase, MTX IT, cyclophosphamide, cytarabine, and thioguanine as in arm I. Patients with intermediate- or high-risk disease (CNS1 or CNS2 disease) undergo prophylactic CRT (1,200 cGy/dose) once daily on days 50-54 and 57-59.
|
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cytarabine
Given IT, IV, or SC
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: vincristine sulfate
Given IV
Other Names:
|
|
Active Comparator: Arm IV (Delayed intensification chemotherapy)
Patients receive vincristine, dexamethasone, doxorubicin hydrochloride, pegaspargase, MTX IT, nelarabine, cyclophosphamide, cytarabine, and thioguanine as in arm II. Patients with intermediate- or high-risk disease (CNS 1 or CNS2 disease) undergo prophylactic CRT on days 50-54 and 57-59.
|
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: cytarabine
Given IT, IV, or SC
Other Names:
Drug: pegaspargase
Given intramuscularly or IV
Other Names:
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: nelarabine
Given IV
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Drug: thioguanine
Given orally
Other Name: 6-TG
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm I (Maintenance chemotherapy)
Patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone twice daily on days 1-5, 29-33, and 57-61; oral mercaptopurine once daily on days 1-84; oral MTX on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and MTX IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL) and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).
|
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm II (Maintenance chemotherapy)
Patients receive vincristine IV on days 1 and 57; oral dexamethasone on days 1-5 and 57-61; oral mercaptopurine once daily on days 1-84; oral MTX on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; MTX IT on day 1; and nelarabine IV over 60 minutes on days 29-33. Treatment (that includes nelarabine) repeats every 84 days for 3 courses. Patients then receive treatment (without nelarabine) as follows: vincristine IV on days 1 and 57; oral dexamethasone on days 1-5, 29-33, and 57-61; oral mercaptopurine on days 1-84; oral MTX on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and MTX IT on day 1. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL) and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).
|
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: nelarabine
Given IV
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm III (Maintenance chemotherapy)
Patients receive vincristine, dexamethasone, mercaptopurine, oral MTX, and MTX IT as in arm I. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL) and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).
|
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Radiation: radiation therapy
Some patients undergo testicular and/or prophylactic cranial RT
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Active Comparator: Arm IV (Maintenance chemotherapy)
Patients receive vincristine, dexamethasone, mercaptopurine, oral MTX, MTX IT, and nelarabine as in arm II. Patients then receive treatment (without nelarabine) as follows: vincristine, dexamethasone, mercaptopurine, oral MTX, and MTX IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL) and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).
|
Drug: methotrexate
Given intrathecally or orally
Other Names:
Drug: mercaptopurine
Given orally
Other Names:
Drug: nelarabine
Given IV
Other Names:
Drug: dexamethasone
Given IV or orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Newly diagnosed with 1 of the following:
T-cell acute lymphoblastic leukemia (ALL), meeting the following criteria:
- Leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation(CD19/CD22/CD20) AND express either surface or cytoplasmic CD3 or two or more of the antigens CD8,CD7, CD5, CD4, CD2 or CD1a
- If surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including TdT, CD34, or CD99 will be assessed for expression
- Concurrently enrolled on protocol COG-AALL03B1 and/or COG-AALL08B1
T-lineage lymphoblastic lymphoma (T-NHL)
Stage II-IV disease
- No B-lineage lymphoblastic lymphoma
- No morphologically unclassifiable lymphoma
- No absence of both B-cell and T-cell phenotype markers
- No CNS3-positive or testicular involvement
- No patients with ALL or T-NHL and Down syndrome
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neurotoxicity ≥ grade 2 (for patients randomized to receive nelarabine)
- No prior seizure disorder (for patients randomized to receive nelarabine)
- Prior steroid therapy allowed
- No prior cytotoxic chemotherapy except intrathecal cytarabine
- At least 2 years since prior and no concurrent anticonvulsant therapy (for patients randomized to receive nelarabine)
- No concurrent milk or citrus products during thioguanine or mercaptopurine administration
- No concurrent intensity-modulated radiotherapy
- No concurrent nonsteroidal anti-inflammatory drugs, penicillin, or acetylsalicylic acid-containing medications for at least 3 days after high-dose methotrexate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408005
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Hide Study LocationsLocations
| United States, Alabama | |
| Children's Hospital of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Alyssa T. Reddy 205-934-0309 | |
| Principal Investigator: Alyssa T. Reddy | |
| University of Alabama at Birmingham | Withdrawn |
| Birmingham, Alabama, United States, 35294 | |
| University of South Alabama | Recruiting |
| Mobile, Alabama, United States, 36604 | |
| Contact: Felicia L. Wilson 251-665-8000 | |
| Principal Investigator: Felicia L. Wilson | |
| United States, Arizona | |
| Phoenix Childrens Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Jessica Boklan 602-546-0920 | |
| Principal Investigator: Jessica Boklan | |
| University of Arizona Health Sciences Center | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| Contact: Brenda J. Wittman 520-626-9008 | |
| Principal Investigator: Brenda J. Wittman | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: David L. Becton 501-364-7373 | |
| Principal Investigator: David L. Becton | |
| United States, California | |
| Southern California Permanente Medical Group | Recruiting |
| Downey, California, United States, 90242 | |
| Contact: Robert M. Cooper 626-564-3455 | |
| Principal Investigator: Robert M. Cooper | |
| City of Hope Medical Center | Active, not recruiting |
| Duarte, California, United States, 91010 | |
| Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Antranik A. Bedros 909-558-3375 | |
| Principal Investigator: Antranik A. Bedros | |
| Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90806 | |
| Contact: Shadi Farzin-Gohar 909-558-3375 | |
| Principal Investigator: Shadi Farzin-Gohar | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Carole H. Hurvitz 310-423-8965 | |
| Principal Investigator: Carole H. Hurvitz | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Leo Mascarenhas 323-361-4110 | |
| Principal Investigator: Leo Mascarenhas | |
| Children's Hospital Central California | Recruiting |
| Madera, California, United States, 93636-8762 | |
| Contact: Vonda L. Crouse 866-353-5437 | |
| Principal Investigator: Vonda L. Crouse | |
| Children's Hospital and Research Center at Oakland | Recruiting |
| Oakland, California, United States, 94609-1809 | |
| Contact: Carla B. Golden 510-450-7600 | |
| Principal Investigator: Carla B. Golden | |
| Kaiser Permanente-Oakland | Recruiting |
| Oakland, California, United States, 94611 | |
| Contact: Vincent A. Kiley 626-564-3455 | |
| Principal Investigator: Vincent A. Kiley | |
| Childrens Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868-3874 | |
| Contact: Violet Shen 714-997-3000 | |
| Principal Investigator: Violet Shen | |
| Lucile Packard Children's Hospital Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Neyssa M. Marina 650-498-7061 clinicaltrials@med.stanford.edu | |
| Principal Investigator: Neyssa M. Marina | |
| UC Davis Comprehensive Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Jay Michael S. Balagtas 916-734-3089 | |
| Principal Investigator: Jay Michael S. Balagtas | |
| Rady Children's Hospital - San Diego | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: William D. Roberts 858-966-5934 | |
| Principal Investigator: William D. Roberts | |
| University of California San Francisco Medical Center-Parnassus | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Mignon L. Loh 877-827-3222 | |
| Principal Investigator: Mignon L. Loh | |
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kelly W. Maloney 720-777-6672 | |
| Principal Investigator: Kelly W. Maloney | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Jennifer J. Clark 866-775-6246 | |
| Principal Investigator: Jennifer J. Clark | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Michael S. Isakoff 860-545-9981 | |
| Principal Investigator: Michael S. Isakoff | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06520-8032 | |
| Contact: Nina S. Kadan-Lottick 203-785-5702 | |
| Principal Investigator: Nina S. Kadan-Lottick | |
| United States, Delaware | |
| Alfred I duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Christopher N. Frantz 302-651-5755 | |
| Principal Investigator: Christopher N. Frantz | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Jeffrey S. Dome 202-884-2549 | |
| Principal Investigator: Jeffrey S. Dome | |
| Lombardi Comprehensive Cancer Center at Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20057 | |
| Contact: Aziza T. Shad 202-444-0381 | |
| Principal Investigator: Aziza T. Shad | |
| United States, Florida | |
| Broward General Medical Center | Recruiting |
| Fort Lauderdale, Florida, United States, 33316 | |
| Contact: Hector M. Rodriguez-Cortes 954-355-5346 | |
| Principal Investigator: Hector M. Rodriguez-Cortes | |
| Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Emad K. Salman 239-343-5333 | |
| Principal Investigator: Emad K. Salman | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: William B. Slayton 352-273-8675 trials@cancer.ufl.edu | |
| Principal Investigator: William B. Slayton | |
| Memorial Healthcare System - Joe DiMaggio Children's Hospital | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Iftikhar Hanif 954-265-2234 | |
| Principal Investigator: Iftikhar Hanif | |
| Nemours Children's Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32207-8426 | |
| Contact: Eric S. Sandler 904-697-3529 | |
| Principal Investigator: Eric S. Sandler | |
| Baptist Hospital of Miami | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Doured Daghistani 800-599-2456 cancerinfo@baptisthealth.net | |
| Principal Investigator: Doured Daghistani | |
| Miami Children's Hospital | Recruiting |
| Miami, Florida, United States, 33155 | |
| Contact: Enrique A. Escalon 305-662-8360 | |
| Principal Investigator: Enrique A. Escalon | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Julio C. Barredo 866-574-5124 Sylvester@emergingmed.com | |
| Principal Investigator: Julio C. Barredo | |
| M D Anderson Cancer Center- Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Vincent F. Giusti 321-841-7246 | |
| Principal Investigator: Vincent F. Giusti | |
| Nemours Childrens Clinic - Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Ramamoorthy Nagasubramanian 407-650-7150 | |
| Principal Investigator: Ramamoorthy Nagasubramanian | |
| Florida Hospital | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Clifford A. Selsky 407-303-5623 | |
| Principal Investigator: Clifford A. Selsky | |
| Nemours Children's Clinic - Pensacola | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Jeffrey H. Schwartz 904-697-3529 | |
| Principal Investigator: Jeffrey H. Schwartz | |
| All Children's Hospital | Recruiting |
| Saint Petersburg, Florida, United States, 33701 | |
| Contact: Gregory A. Hale 727-767-2423 HamblinF@allkids.org | |
| Principal Investigator: Gregory A. Hale | |
| Saint Joseph Children's Hospital of Tampa | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Hardeo K. Panchoosingh 800-882-4123 | |
| Principal Investigator: Hardeo K. Panchoosingh | |
| Saint Mary's Hospital | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| Contact: Narayana Gowda 888-823-5923 ctsucontact@westat.com | |
| Principal Investigator: Narayana Gowda | |
| United States, Georgia | |
| Children's Healthcare of Atlanta - Egleston | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Howard M. Katzenstein 888-785-1112 | |
| Principal Investigator: Howard M. Katzenstein | |
| Georgia Health Sciences University | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Colleen H. McDonough 706-721-1663 cancer@georgiahealth.edu | |
| Principal Investigator: Colleen H. McDonough | |
| Memorial Health University Medical Center | Recruiting |
| Savannah, Georgia, United States, 31403 | |
| Contact: J. Martin Johnston 912-350-8568 | |
| Principal Investigator: J. Martin Johnston | |
| United States, Hawaii | |
| Tripler Army Medical Center | Recruiting |
| Honolulu, Hawaii, United States, 96859 | |
| Contact: Tonya M. Kratovil 808-433-6336 | |
| Principal Investigator: Tonya M. Kratovil | |
| University of Hawaii | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Robert W. Wilkinson 808-983-6090 | |
| Principal Investigator: Robert W. Wilkinson | |
| United States, Idaho | |
| Saint Luke's Mountain States Tumor Institute | Withdrawn |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Childrens Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: David O. Walterhouse 773-880-4562 | |
| Principal Investigator: David O. Walterhouse | |
| University of Chicago Comprehensive Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Susan L. Cohn 773-834-7424 | |
| Principal Investigator: Susan L. Cohn | |
| University of Illinois | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Mary L. Schmidt 312-355-3046 | |
| Principal Investigator: Mary L. Schmidt | |
| Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Ricarchito B. Manera 708-226-4357 | |
| Principal Investigator: Ricarchito B. Manera | |
| Advocate Hope Children's Hospital | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Sharad N. Salvi 847-723-7570 | |
| Principal Investigator: Sharad N. Salvi | |
| Advocate Lutheran General Hospital | Recruiting |
| Park Ridge, Illinois, United States, 60068 | |
| Contact: Jong H. Kwon 847-384-3621 | |
| Principal Investigator: Jong H. Kwon | |
| Southern Illinois University | Recruiting |
| Springfield, Illinois, United States, 62702 | |
| Contact: Gregory P. Brandt 217-545-7929 | |
| Principal Investigator: Gregory P. Brandt | |
| United States, Indiana | |
| Riley Hospital for Children | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Robert J. Fallon 317-274-2552 | |
| Principal Investigator: Robert J. Fallon | |
| Saint Vincent Hospital and Health Services | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Bassem I. Razzouk 317-338-2194 | |
| Principal Investigator: Bassem I. Razzouk | |
| United States, Iowa | |
| Raymond Blank Children's Hospital | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Wendy L. Woods-Swafford 888-823-5923 ctsucontact@westat.com | |
| Principal Investigator: Wendy L. Woods-Swafford | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Raymond Tannous 800-237-1225 | |
| Principal Investigator: Raymond Tannous | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Martha F. Greenwood 859-257-3379 | |
| Principal Investigator: Martha F. Greenwood | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Salvatore J. Bertolone 866-530-5516 | |
| Principal Investigator: Salvatore J. Bertolone | |
| United States, Louisiana | |
| Children's Hospital-Main Campus | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Lolie C. Yu 504-894-5377 | |
| Principal Investigator: Lolie C. Yu | |
| Ochsner Clinic Foundation | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Rajasekharan (Raj) P. Warrier 504-894-5377 | |
| Principal Investigator: Rajasekharan (Raj) P. Warrier | |
| Tulane University Health Sciences Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Tammuella C. Singleton 504-988-6121 | |
| Principal Investigator: Tammuella C. Singleton | |
| United States, Maine | |
| Eastern Maine Medical Center | Recruiting |
| Bangor, Maine, United States, 04401 | |
| Contact: Sarah J. Fryberger 207-973-4274 | |
| Principal Investigator: Sarah J. Fryberger | |
| Maine Children's Cancer Program | Recruiting |
| Scarborough, Maine, United States, 04074 | |
| Contact: Eric C. Larsen 207-396-8090 wrighd@mmc.org | |
| Principal Investigator: Eric C. Larsen | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287-8936 | |
| Contact: Patrick A. Brown 410-955-8804 jhcccro@jhmi.edu | |
| Principal Investigator: Patrick A. Brown | |
| Sinai Hospital of Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21215 | |
| Contact: Joseph M. Wiley 410-601-6120 pridgely@lifebridgehealth.org | |
| Principal Investigator: Joseph M. Wiley | |
| University of Maryland Greenebaum Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21201-1595 | |
| Contact: Teresa A. York 800-888-8823 | |
| Principal Investigator: Teresa A. York | |
| Walter Reed National Military Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20889-5600 | |
| Contact: Anne B. Warwick 301-319-2100 | |
| Principal Investigator: Anne B. Warwick | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Howard J. Weinstein 877-726-5130 | |
| Principal Investigator: Howard J. Weinstein | |
| University of Massachusetts Medical School | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Christopher P. Keuker 508-856-2464 laura.lefko@umassmed.edu | |
| Principal Investigator: Christopher P. Keuker | |
| United States, Michigan | |
| C S Mott Children's Hospital | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Raymond J. Hutchinson 800-865-1125 | |
| Principal Investigator: Raymond J. Hutchinson | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Jeffrey W. Taub 313-576-9363 | |
| Principal Investigator: Jeffrey W. Taub | |
| Saint John Hospital and Medical Center | Recruiting |
| Detroit, Michigan, United States, 48236 | |
| Contact: Hadi Sawaf 313-343-3166 | |
| Principal Investigator: Hadi Sawaf | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48502 | |
| Contact: Susumu Inoue 888-606-6556 | |
| Principal Investigator: Susumu Inoue | |
| Helen DeVos Children's Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: David S. Dickens 616-267-1925 | |
| Principal Investigator: David S. Dickens | |
| Kalamazoo Center for Medical Studies | Withdrawn |
| Kalamazoo, Michigan, United States, 49008 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Jeffrey S. Lobel 800-227-2345 | |
| Principal Investigator: Jeffrey S. Lobel | |
| Michigan State University - Breslin Cancer Center | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Renuka Gera 517-334-2765 | |
| Principal Investigator: Renuka Gera | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Bruce C. Bostrom 612-813-5193 | |
| Principal Investigator: Bruce C. Bostrom | |
| University of Minnesota Medical Center-Fairview | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Michael J. Burke 612-624-2620 | |
| Principal Investigator: Michael J. Burke | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Vilmarie Rodriguez 507-538-7623 | |
| Principal Investigator: Vilmarie Rodriguez | |
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: Gail C. Megason 601-815-6700 | |
| Principal Investigator: Gail C. Megason | |
| United States, Missouri | |
| University of Missouri-Columbia | Recruiting |
| Columbia, Missouri, United States, 65212 | |
| Contact: Thomas W. Loew 573-882-7440 | |
| Principal Investigator: Thomas W. Loew | |
| The Childrens Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine L. Hetherington 816-234-3265 | |
| Principal Investigator: Maxine L. Hetherington | |
| Saint John's Mercy Medical Center | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Bethany G. Sleckman 913-948-5588 | |
| Principal Investigator: Bethany G. Sleckman | |
| Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Robert J. Hayashi 800-600-3606 info@siteman.wustl.edu | |
| Principal Investigator: Robert J. Hayashi | |
| United States, Nebraska | |
| Children's Hospital and Medical Center of Omaha | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| Contact: Minnie Abromowitch 402-955-3949 | |
| Principal Investigator: Minnie Abromowitch | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Peter F. Coccia 800-999-5465 | |
| Principal Investigator: Peter F. Coccia | |
| United States, Nevada | |
| Nevada Cancer Research Foundation CCOP | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| Contact: Jonathan Bernstein 702-384-0013 | |
| Principal Investigator: Jonathan Bernstein | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756 | |
| Contact: Sara Chaffee 800-639-6918 cancer.research.nurse@dartmouth.edu | |
| Principal Investigator: Sara Chaffee | |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Burton E. Appel 201-996-2879 | |
| Principal Investigator: Burton E. Appel | |
| Saint Barnabas Medical Center | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| Contact: Stacey Rifkin-Zenenberg 973-926-7230 | |
| Principal Investigator: Stacey Rifkin-Zenenberg | |
| Morristown Memorial Hospital | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: Steven L. Halpern 973-971-5900 | |
| Principal Investigator: Steven L. Halpern | |
| Saint Peter's University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Stanley Calderwood 732-745-8600 ext 6163 kcovert@saintpetersuh.com | |
| Principal Investigator: Stanley Calderwood | |
| UMDNJ - Robert Wood Johnson University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Richard A. Drachtman 732-235-8675 | |
| Principal Investigator: Richard A. Drachtman | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Peri Kamalakar 973-926-7230 | |
| Principal Investigator: Peri Kamalakar | |
| Saint Joseph's Regional Medical Center | Recruiting |
| Paterson, New Jersey, United States, 07503 | |
| Contact: Mary A. Bonilla 973-754-2909 | |
| Principal Investigator: Mary A. Bonilla | |
| Overlook Hospital | Withdrawn |
| Summit, New Jersey, United States, 07902 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Koh B. Boayue 505-272-6972 | |
| Principal Investigator: Koh B. Boayue | |
| United States, New York | |
| Albany Medical Center | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact: Vikramjit S. Kanwar 518-262-3368 | |
| Principal Investigator: Vikramjit S. Kanwar | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467-2490 | |
| Contact: Rosanna J. Ricafort 718-904-2730 aecc@aecom.yu.edu | |
| Principal Investigator: Rosanna J. Ricafort | |
| Brooklyn Hospital Center | Active, not recruiting |
| Brooklyn, New York, United States, 11201 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Martin L. Brecher 877-275-7724 | |
| Principal Investigator: Martin L. Brecher | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Mark E. Weinblatt 866-946-8476 | |
| Principal Investigator: Mark E. Weinblatt | |
| The Steven and Alexandra Cohen Children's Medical Center of New York | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Arlene S. Redner 718-470-3470 | |
| Principal Investigator: Arlene S. Redner | |
| New York University Langone Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Elizabeth A. Raetz 212-263-4434 prmc.coordinator@nyumc.org | |
| Principal Investigator: Elizabeth A. Raetz | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Birte Wistinghausen 212-824-7320 jenny.figueroa@mssm.edu | |
| Principal Investigator: Birte Wistinghausen | |
| Weill Medical College of Cornell University | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Alexander Aledo 212-746-1848 | |
| Principal Investigator: Alexander Aledo | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jeffrey R. Andolina 585-275-5830 | |
| Principal Investigator: Jeffrey R. Andolina | |
| State University of New York Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Karol H. Kerr 315-464-5476 | |
| Principal Investigator: Karol H. Kerr | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Mehmet F. Ozkaynak 914-594-3794 | |
| Principal Investigator: Mehmet F. Ozkaynak | |
| United States, North Carolina | |
| Mission Hospitals Inc | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Orren Beaty 828-213-4150 | |
| Principal Investigator: Orren Beaty | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Stuart H. Gold 877-668-0683 | |
| Principal Investigator: Stuart H. Gold | |
| Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Paulette C. Bryant 704-384-5369 | |
| Principal Investigator: Paulette C. Bryant | |
| Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Joel A. Kaplan 704-355-2884 | |
| Principal Investigator: Joel A. Kaplan | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Susan G. Kreissman 888-275-3853 | |
| Principal Investigator: Susan G. Kreissman | |
| East Carolina University | Recruiting |
| Greenville, North Carolina, United States, 27858 | |
| Contact: Mauro Grossi 252-744-2161 | |
| Principal Investigator: Mauro Grossi | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Thomas W. McLean 336-713-6771 | |
| Principal Investigator: Thomas W. McLean | |
| United States, North Dakota | |
| Sanford Medical Center-Fargo | Recruiting |
| Fargo, North Dakota, United States, 58122 | |
| Contact: Nathan L. Kobrinsky 701-234-6161 | |
| Principal Investigator: Nathan L. Kobrinsky | |
| United States, Ohio | |
| Children's Hospital Medical Center of Akron | Recruiting |
| Akron, Ohio, United States, 44308 | |
| Contact: Steven J. Kuerbitz 330-543-3193 | |
| Principal Investigator: Steven J. Kuerbitz | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: John P. Perentesis 513-636-2799 | |
| Principal Investigator: John P. Perentesis | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Tanya M. Tekautz 866-223-8100 | |
| Principal Investigator: Tanya M. Tekautz | |
| Rainbow Babies and Childrens Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Yousif (Joe) H. Matloub 216-844-5437 | |
| Principal Investigator: Yousif (Joe) H. Matloub | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Laura T. Martin 614-722-2708 | |
| Principal Investigator: Laura T. Martin | |
| The Children's Medical Center of Dayton | Recruiting |
| Dayton, Ohio, United States, 45404 | |
| Contact: Emmett H. Broxson 800-228-4055 | |
| Principal Investigator: Emmett H. Broxson | |
| Mercy Children's Hospital | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Rama Jasty 419-251-8210 | |
| Principal Investigator: Rama Jasty | |
| The Toledo Hospital/Toledo Children's Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Dagmar T. Stein 419-824-1842 | |
| Principal Investigator: Dagmar T. Stein | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-4272 julie-traylor@ouhsc.edu | |
| Principal Investigator: Rene Y. McNall-Knapp | |
| Natalie W Bryant Cancer Center | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Gregory B. Kirkpatrick 918-494-2200 | |
| Principal Investigator: Gregory B. Kirkpatrick | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center | Withdrawn |
| Portland, Oregon, United States, 97227 | |
| Legacy Emanuel Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Janice F. Olson 503-413-2560 | |
| Principal Investigator: Janice F. Olson | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Linda C. Stork 503-494-1080 trials@ohsu.edu | |
| Principal Investigator: Linda C. Stork | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Philip M. Monteleone 484-884-2201 | |
| Principal Investigator: Philip M. Monteleone | |
| Geisinger Medical Center | Recruiting |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Contact: Jeffrey S. Taylor 570-271-5251 | |
| Principal Investigator: Jeffrey S. Taylor | |
| Penn State Hershey Children's Hospital | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: John F. Kuttesch 505-272-6972 CTO@hmc.psu.edu | |
| Principal Investigator: John F. Kuttesch | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Frank M. Balis 215-590-2810 | |
| Principal Investigator: Frank M. Balis | |
| Saint Christopher's Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19134 | |
| Contact: Gregory E. Halligan 215-427-8991 | |
| Principal Investigator: Gregory E. Halligan | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Arthur K. Ritchey 412-692-5573 | |
| Principal Investigator: Arthur K. Ritchey | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Jacqueline M. Kraveka 843-792-9321 | |
| Principal Investigator: Jacqueline M. Kraveka | |
| Palmetto Health Richland | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Ronnie W. Neuberg 803-434-3680 | |
| Principal Investigator: Ronnie W. Neuberg | |
| Greenville Cancer Treatment Center | Withdrawn |
| Greenville, South Carolina, United States, 29605 | |
| BI-LO Charities Children's Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Nichole L. Bryant 864-241-6251 | |
| Principal Investigator: Nichole L. Bryant | |
| United States, South Dakota | |
| Sanford USD Medical Center - Sioux Falls | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5134 | |
| Contact: Kayelyn J. Wagner 605-328-1367 | |
| Principal Investigator: Kayelyn J. Wagner | |
| United States, Tennessee | |
| T C Thompson Children's Hospital | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Manoo G. Bhakta 423-778-7289 | |
| Principal Investigator: Manoo G. Bhakta | |
| East Tennessee Childrens Hospital | Recruiting |
| Knoxville, Tennessee, United States, 37916 | |
| Contact: Ray C. Pais 865-541-8266 | |
| Principal Investigator: Ray C. Pais | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Haydar A. Frangoul 800-811-8480 | |
| Principal Investigator: Haydar A. Frangoul | |
| United States, Texas | |
| Texas Tech University Health Science Center-Amarillo | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Osvaldo Regueira 806-354-5411 | |
| Principal Investigator: Osvaldo Regueira | |
| Dell Children's Medical Center of Central Texas | Recruiting |
| Austin, Texas, United States, 78723 | |
| Contact: Sharon K. Lockhart 512-324-8022 | |
| Principal Investigator: Sharon K. Lockhart | |
| Driscoll Children's Hospital | Recruiting |
| Corpus Christi, Texas, United States, 78411 | |
| Contact: M. Cris Johnson 361-694-5311 | |
| Principal Investigator: M. Cris Johnson | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Naomi J. Winick 214-648-7097 | |
| Principal Investigator: Naomi J. Winick | |
| Medical City Dallas Hospital | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Carl Lenarsky 972-566-5588 | |
| Principal Investigator: Carl Lenarsky | |
| Cook Children's Medical Center | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Mary Meaghan P. Granger 682-885-2103 | |
| Principal Investigator: Mary Meaghan P. Granger | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Lisa R. Bomgaars 713-798-1354 burton@bcm.edu | |
| Principal Investigator: Lisa R. Bomgaars | |
| Covenant Children's Hospital | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Latha Prasannan 806-725-8000 jaccresearch@covhs.org | |
| Principal Investigator: Latha Prasannan | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229-3900 | |
| Contact: Anne-Marie R. Langevin 210-567-0653 che@uthscsa.edu | |
| Principal Investigator: Anne-Marie R. Langevin | |
| Methodist Children's Hospital of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Jaime Estrada 210-575-7000 | |
| Principal Investigator: Jaime Estrada | |
| Scott and White Memorial Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Guy H. Grayson 254-724-5407 | |
| Principal Investigator: Guy H. Grayson | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113 | |
| Contact: Phillip E. Barnette 801-585-5270 | |
| Principal Investigator: Phillip E. Barnette | |
| United States, Vermont | |
| University of Vermont | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Alan C. Homans 802-656-8990 | |
| Principal Investigator: Alan C. Homans | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Kimberly P. Dunsmore 434-243-6143 | |
| Principal Investigator: Kimberly P. Dunsmore | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042 | |
| Contact: Marshall A. Schorin 703-208-6650 | |
| Principal Investigator: Marshall A. Schorin | |
| Childrens Hospital-King's Daughters | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Eric J. Lowe 757-668-7243 | |
| Principal Investigator: Eric J. Lowe | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Kamar Godder 804-628-1939 | |
| Principal Investigator: Kamar Godder | |
| Carilion Clinic Children's Hospital | Recruiting |
| Roanoke, Virginia, United States, 24014 | |
| Contact: Mandy M. Atkinson 540-981-7376 | |
| Principal Investigator: Mandy M. Atkinson | |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Blythe G. Thomson 866-987-2000 | |
| Principal Investigator: Blythe G. Thomson | |
| Providence Sacred Heart Medical Center and Children's Hospital | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Judy L. Felgenhauer 800-228-6618 HopeBeginsHere@providence.org | |
| Principal Investigator: Judy L. Felgenhauer | |
| Mary Bridge Children's Hospital and Health Center | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Robert G. Irwin 888-823-5923 ctsucontact@westat.com | |
| Principal Investigator: Robert G. Irwin | |
| Madigan Army Medical Center | Recruiting |
| Tacoma, Washington, United States, 98431 | |
| Contact: Melissa A. Forouhar 253-968-0129 mamcdci@amedd.army.mil | |
| Principal Investigator: Melissa A. Forouhar | |
| United States, West Virginia | |
| West Virginia University Charleston | Recruiting |
| Charleston, West Virginia, United States, 25304 | |
| Contact: Allen R. Chauvenet 304-388-9944 | |
| Principal Investigator: Allen R. Chauvenet | |
| United States, Wisconsin | |
| Saint Vincent Hospital | Recruiting |
| Green Bay, Wisconsin, United States, 54301 | |
| Contact: John R. Hill 920-433-8889 | |
| Principal Investigator: John R. Hill | |
| University of Wisconsin Hospital and Clinics | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Kenneth B. De Santes 608-262-5223 | |
| Principal Investigator: Kenneth B. De Santes | |
| Marshfield Clinic | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Michael J. McManus 715-389-4457 | |
| Principal Investigator: Michael J. McManus | |
| Midwest Children's Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Michael G. Kelly 336-713-6771 ContactUsCancerCenter@TuftsMedicalCenter.org | |
| Principal Investigator: Michael G. Kelly | |
| Australia, Queensland | |
| Royal Brisbane and Women's Hospital | Withdrawn |
| Herston, Queensland, Australia, 4029 | |
| Royal Childrens Hospital | Recruiting |
| Herston, Queensland, Australia, 4029 | |
| Contact: Christopher J. Fraser 888-823-5923 ctsucontact@westat.com | |
| Principal Investigator: Christopher J. Fraser | |
| Australia, South Australia | |
| Women's and Children's Hospital-Adelaide | Recruiting |
| North Adelaide, South Australia, Australia, 5006 | |
| Contact: Maria L. Kirby (08) 8161 7327 cywhs.oncsec@health.sa.gov.au | |
| Principal Investigator: Maria L. Kirby | |
| Australia, Victoria | |
| Royal Children's Hospital | Recruiting |
| Parkville, Victoria, Australia, 3052 | |
| Contact: Francoise M. Mechinaud crdo.info@mcri.edu.au | |
| Principal Investigator: Francoise M. Mechinaud | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6008 | |
| Contact: Catherine H. Cole (08) 9340 8330 admin@childcancerresearch.com.au | |
| Principal Investigator: Catherine H. Cole | |
| Canada, Alberta | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Contact: Douglas R. Strother 403-220-6898 research4kids@ucalgary.ca | |
| Principal Investigator: Douglas R. Strother | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Sunil Jayantilal` S. Desai 780-407-6615 val.taylor@albertahealthservices.ca | |
| Principal Investigator: Sunil Jayantilal` S. Desai | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Caron Strahlendorf 604-875-2345ext6477 | |
| Principal Investigator: Caron Strahlendorf | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Rochelle A. Yanofsky 866-561-1026 CIO_Web@cancercare.mb.ca | |
| Principal Investigator: Rochelle A. Yanofsky | |
| Canada, Newfoundland and Labrador | |
| Janeway Child Health Centre | Recruiting |
| Saint John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Contact: Lisa Anne B. Goodyear 866-722-1126 | |
| Principal Investigator: Lisa Anne B. Goodyear | |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| Contact: Margaret C. Yhap 902-470-8394 | |
| Principal Investigator: Margaret C. Yhap | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Contact: Mariana P. Silva 613-544-2630 | |
| Principal Investigator: Mariana P. Silva | |
| Children's Hospital | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Anne E. Cairney 519-685-8306 | |
| Principal Investigator: Anne E. Cairney | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Contact: Jacqueline M. Halton 613-738-3931 | |
| Principal Investigator: Jacqueline M. Halton | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Sheila Weitzman 416-813-7654ext2027 jason.mcguire@sickkids.ca | |
| Principal Investigator: Sheila Weitzman | |
| Canada, Quebec | |
| The Montreal Children's Hospital of the MUHC | Recruiting |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Contact: Sharon B. Abish 514-412-4445 info@thechildren.com | |
| Principal Investigator: Sharon B. Abish | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | Recruiting |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Contact: Mansoor M. Haq 306-766-2213 | |
| Principal Investigator: Mansoor M. Haq | |
| Saskatoon Cancer Centre | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Christopher Mpofu 306-655-2914 | |
| Principal Investigator: Christopher Mpofu | |
| New Zealand | |
| Starship Children's Hospital | Recruiting |
| Grafton, Auckland, New Zealand, 1145 | |
| Contact: Lochie R. Teague 0800 728 436 | |
| Principal Investigator: Lochie R. Teague | |
| Christchurch Hospital | Recruiting |
| Christchurch, New Zealand, 8011 | |
| Contact: Michael J. Sullivan 03 364 0640 | |
| Principal Investigator: Michael J. Sullivan | |
| Switzerland | |
| Swiss Pediatric Oncology Group - Geneva | Recruiting |
| Geneva, Switzerland, 1205 | |
| Contact: Ayse H. Ozsahin 031 389 91 89 | |
| Principal Investigator: Ayse H. Ozsahin | |
| Swiss Pediatric Oncology Group - Lausanne | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Maja Beck Popovic 31 389 91 89 | |
| Principal Investigator: Maja Beck Popovic | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Stuart Winter | Children's Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00408005 History of Changes |
| Other Study ID Numbers: | NCI-2009-00307, AALL0434, CDR0000514500, COG-AALL0434, U01CA98543 |
| Study First Received: | December 4, 2006 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma Lymphoma, Non-Hodgkin Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine |
Cytarabine Methotrexate Thioguanine Cyclophosphamide Pegaspargase Asparaginase Daunorubicin Dexamethasone Doxorubicin Prednisone Vincristine BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Leucovorin |
ClinicalTrials.gov processed this record on May 23, 2013