Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02883049 |
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Recruitment Status :
Recruiting
First Posted : August 30, 2016
Last Update Posted : June 12, 2018
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
- Study Details
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Brief Summary:
This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia | Drug: Clofarabine Drug: Cyclophosphamide Drug: Cytarabine Drug: Dasatinib Drug: Dexamethasone Drug: Doxorubicin Hydrochloride Drug: Etoposide Drug: Hydrocortisone Sodium Succinate Other: Laboratory Biomarker Analysis Drug: Leucovorin Calcium Drug: Mercaptopurine Drug: Methotrexate Drug: Pegaspargase Drug: Prednisone Radiation: Radiation Therapy Drug: Thioguanine Drug: Vincristine Sulfate | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 5956 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-Like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations |
| Actual Study Start Date : | February 27, 2012 |
| Estimated Primary Completion Date : | June 30, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm A (VHR B-ALL C)
Patients receive consolidation therapy comprising cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; mercaptopurine PO QD on days 29-42; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given PO
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Active Comparator: Arm A (VHR B-ALL DI)
Patients receive DI therapy comprising cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; thioguanine PO QD on days 29-42; methotrexate IT on days 29 and 36; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Methotrexate Given IT and IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm B (VHR B-ALL C)
Patients receive consolidation therapy comprising cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on days 29-33; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Pegaspargase Given IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm B (VHR B-ALL DI)
Patients receive DI therapy comprising cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on days 29-33; methotrexate IT on days 29 and 36; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Methotrexate Given IT and IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm C (VHR B-ALL C)
Patients receive clofarabine IV over 2 hours on days 29-33 and consolidation therapy as in Arm B VHR B-ALL C. (Closed as of 9/12/2014)
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Drug: Clofarabine
Given IV
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Pegaspargase Given IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm C (VHR B-ALL DI)
Patients receive clofarabine IV over 2 hours on days 29-33 and DI therapy as in Arm II B VHR B-ALL DI. (Closed as of 9/12/2014)
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Drug: Clofarabine
Given IV
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Methotrexate Given IT and IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Active Comparator: Arm I (HR B-ALL C)
Patients receive Consolidation therapy comprising cyclophosphamide IV over 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO QD on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22; vincristine sulfate IV over 1 minute on days 15, 22, 43, and 50; and pegaspargase IV over 1-2 hours on days 15 and 43. Patients with continuing clinical evidence of testicular leukemia undergo RT QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT and IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Active Comparator: Arm I (HR B-ALL DI)
Patients receive DI therapy comprising vincristine sulfate IV over 1 hour on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-7 and 15-21; doxorubicin hydrochloride IV over 1-60 minutes on days 1, 8, and 15; methotrexate IT on days 1, 29, and 36; pegaspargase IV over 1-2 hours on days 4 and 43; cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO QD on days 29-42. Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Drug: Dexamethasone PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Methotrexate Given IT and IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Active Comparator: Arm I (HR B-ALL IM)
Patients receive IM therapy comprising vincristine sulfate IV over 1 minute on days 1, 15, 29, and 43; high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46; methotrexate IT on days 1 and 29; and mercaptopurine PO on days 1-56. Treatment continues for 63 days in the absence of disease progression or unacceptable toxicity.
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Other: Laboratory Biomarker Analysis
Correlative studies Drug: Leucovorin Calcium Given PO or IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT and IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Active Comparator: Arm I (HR B-ALL M)
Patients receive maintenance therapy comprising vincristine sulfate IV over 1 minute on days 1, 29, and 57; methotrexate IT on day 1 (also day 29 of courses 1-4); prednisone PO BID on days 1-5, 29-33 (may receive methylprednisolone IV if PO is not tolerated), and 57-61; mercaptopurine PO QD on days 1-84; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence of disease progression or unacceptable toxicity.
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Other: Laboratory Biomarker Analysis
Correlative studies Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT and IV
Other Names:
Drug: Prednisone Given PO or IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm II (HR B-ALL C)
Patients receive Consolidation therapy as patients in Arm I HR B-ALL C. Patients also receive ITT comprising methotrexate, hydrocortisone sodium succinate, and cytarabine on days 1, 8, 15, and 22. Patients with testicular leukemia also undergo RT as in Arm I HR B-ALL C.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Drug: Hydrocortisone Sodium Succinate Given IT
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT and IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
|
|
Experimental: Arm II (HR B-ALL DI)
Patients receive ITT on days 1, 29, and 36 and DI therapy as in Arm I HR B-ALL DI.
|
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Drug: Dexamethasone PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Hydrocortisone Sodium Succinate Given IT
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Pegaspargase Given IV
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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|
Experimental: Arm II (HR B-ALL IM)
Patients receive ITT on days 1 and 29 and IM therapy as in Arm I HR B-ALL IM. Treatment continues for 63 days in the absence of disease progression or unacceptable toxicity.
|
Drug: Hydrocortisone Sodium Succinate
Given IT
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT and IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
|
|
Experimental: Arm II (HR B-ALL M)
Patients receive ITT on day 1 (also day 29 of courses 1-4) and maintenance therapy as in Arm I HR B-ALL M. Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence of disease progression or unacceptable toxicity.
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Drug: Hydrocortisone Sodium Succinate
Given IT
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT and IV
Other Names:
Drug: Prednisone Given PO or IV
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Ph-like TKI-sensitive kinase mutation
Patients receive dasatinib PO QD on days 1-56, cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32 and 36-39, mercaptopurine PO on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15 and 22, vincristine IV over 1 minute on days 15, 22, 43 and 50, and pegaspargase IV over 1-2 hours on days 15 and 43.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, IV, or SC
Other Names:
Drug: Dasatinib Given PO
Other Names:
Drug: Dexamethasone PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Leucovorin Calcium Given PO or IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT and IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Drug: Prednisone Given PO or IV
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Primary Outcome Measures :
- Comparison of disease-free survival (DFS) of children with high-risk (HR) B-acute lymphoblastic leukemia (ALL) [ Time Frame: At 5 years ]DFS of children with HR B-acute ALL receiving post-induction age adjusted intrathecal triple therapy (ITT) on an Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance high-dose methotrexate (IMHDM) backbone will be compared to age adjusted intrathecal (IT) methotrexate (MTX). Compared using 2-sided log rank test, alpha = 5%.
- DFS of children, adolescents, and young adults with very high-risk (VHR) B-ALL between arms [ Time Frame: At 4 years ]DFS of children, adolescents, and young adults with VHR B-ALL will be compared in all arms using 1-sided log rank test, alpha 0.025.
Secondary Outcome Measures :
- Toxicity and tolerability of post-induction age-adjusted ITT compared to age-adjusted IT MTX in children with HR B-ALL [ Time Frame: Up to 10 years ]Graded using the version 5.0 Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI).
- Toxicity and tolerability of Experimental arm and Control arm in patients with VHR B-ALL [ Time Frame: Up to 10 years ]Graded using the version 5.0 CTCAE of the NCI.
- Increase of greater than or equal to 65% of 5-year DFS and less than 10% induction mortality in patients with Down syndrome (DS) and HR B-ALL treated with modified Induction and post-Induction therapy regimen with MBFM-IMIDM [ Time Frame: At 5 years ]
- Children and young adults with Ph-like B-ALL and a predicted tyrosine kinase inhibitor (TKI)-sensitive mutation treated with dasatinib plus MBFM-IMHDM [ Time Frame: Up to 10 years ]
- Toxicity and tolerability of MBFM-IMIDM in children with Down syndrome [ Time Frame: Up to 10 years ]Graded using the version 5.0 CTCAE of the NCI.
- Percentage of VHR-ALL patients randomized to control versus experimental arms that attain MRD less than or equal to 0.01% upon recovery from consolidation [ Time Frame: Week 13-14 ]Compared between control vs experimental arms.
- Overall survival (OS) rate for HR B-ALL patients [ Time Frame: At 5 years ]Compared informally between arms.
- OS rate for VHR B-ALL patients [ Time Frame: At 4 years ]Compared informally between arms.
Other Outcome Measures:
- Change in the minimal residual disease (MRD) from end-Induction to end-Consoldiation [ Time Frame: Baseline to up to 10 years ]Whether the reduction of MRD from end-Induction to end-Consolidation is greater for children, adolescents, and young adults with VHR B-ALL receiving Experimental Arms 1 and/or 2 compared to the Control Arm will be determined.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Year to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must be enrolled on AALL08B1 or APEC14B1 (if available for ALL patients) prior to enrollment on AALL1131
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White Blood Cell Count (WBC) Criteria
- Age 1-9.99 years: WBC >= 50 000/uL
- Age 10-30.99 years: Any WBC
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Age 1-30.99 years: Any WBC with:
- Testicular leukemia
- CNS leukemia (CNS3)
- Steroid pretreatment
- Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible
- Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131
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Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- Age: Maximum Serum Creatinine (mg/dL)
- 1 to < 6 months: 0.4 (male) 0.4 (female)
- 6 months to < 1 year: 0.5 (male) 0.5 (female)
- 1 to < 2 years: 0.6 (male) 0.6 (female)
- 2 < 6 years: 0.8 (male) 0.8 (female)
- 6 to < 10 years: 1.0 (male) 1.0 (female)
- 10 to < 13 years: 1.2 (male) 1.2 (female)
- 13 to < 16 years: 1.5 (male) 1.4 (female)
- > 16 years: 1.7 (male) 1.4 (female)
- Direct bilirubin =< 3 x upper limit of normal (ULN) for age, and
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 10 x upper limit of normal (ULN) for age
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Shortening fraction >= 27% by echocardiogram, or ejection fraction >= 50% by gated radionuclide study
- Patients must have an electrocardiogram (EKG) fewer than 6 days prior to enrollment on the dasatinib arm; patients who have had cardiac assessments by echocardiogram or radionuclide scan at the beginning of induction do not need to have these repeated prior to study entry; correct QT interval (QTc) < 450 msec on baseline electrocardiogram as measured by the Frederica or Bazett formula
- No major conduction abnormality (unless a cardiac pacemaker is present)
- No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at sea level if there is clinical indication for determination
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine, phenytoin, primidone, phenobarbital) should be avoided
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Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive Functioning study
- Patients must be aged 6 to 13 years at time of B-ALL diagnosis, enrolled on AALL1131
- Patients must be English-, French- or Spanish-speaking (languages in which the assessment is available)
- Patients must have no known history of neurodevelopmental disorder prior to diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William's Syndrome, mental retardation)
- Patients must have no significant visual impairment that would prevent computer use and recognition of the visual test stimuli
- Eligibility criteria for the National Cancer Institute (NCI) standard risk patients from AALL0932 enrolling on this study at the end of Induction
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Patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the HR B-ALL stratum of this study at the end of Induction:
- Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day 8 peripheral blood (PB) minimal residual disease (MRD) >= 1% and day 29 BM MRD < 0.01%
- With favorable cytogenetics (ETV6-RUNX1 or double trisomies 4+10), with any day 8 PB MRD and day 29 bone marrow (BM) MRD >= 0.01%
- Both NCI standard risk (SR) and HR patients without Down syndrome and with testicular disease at diagnosis, who do not meet other VHR criteria, will be eligible for the HR stratum
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Effective Amendment 6, patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 or the VHR stratum of AALL1131:
- Intrachromosomal amplification of chromosome 21 (iAMP21)
- Mixed-lineage leukemia (MLL) rearrangement
- Hypodiploidy (n < 44 chromosomes and/or a deoxyribonucleic acid [DNA] index < 0.81)
- Induction failure (M3 BM at day 29)
- Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day 29 BM MRD >= 0.01%
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Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR B-ALL stratum of this study at the end of Induction:
- Day 29 MRD >= 0.01%
- MLL rearrangement
- Hypodiploidy (n < 45 chromosomes and/or DNA index < 0.81)
- DS HR B-ALL patients initially enrolled on AALL0932 or this study who have Induction failure (M3 BM day 29) or Philadelphia chromosome (BCR-ABL1) will not be eligible for post-Induction therapy on either trial (AALL0932 or AALL1131)
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met
Exclusion Criteria:
- With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131
- Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction
- DS HR B-ALL patients with Induction failure or BCR-ABL1
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed their infant
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883049
Show 239 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Michael Burke | Children's Oncology Group |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT02883049 History of Changes |
| Obsolete Identifiers: | NCT01406756 |
| Other Study ID Numbers: |
NCI-2011-03797 NCI-2011-03797 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000706370 AALL1131 COG-AALL1131 S12-01254 AALL1131 ( Other Identifier: Childrens Oncology Group ) AALL1131 ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 30, 2016 Key Record Dates |
| Last Update Posted: | June 12, 2018 |
| Last Verified: | April 2018 |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Cortisone acetate Dexamethasone |
Prednisone Hydrocortisone Cortisone Liposomal doxorubicin Etoposide phosphate Clofarabine Pegaspargase Cyclophosphamide Doxorubicin Methotrexate Etoposide Cytarabine Vincristine Dasatinib Asparaginase |