Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00557193
First received: November 9, 2007
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells or by stopping them from dividing. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with lestaurtinib may kill more cancer cells.
PURPOSE: This phase III trial is studying giving lestaurtinib together with combination chemotherapy to see how well it works compared to combination chemotherapy alone in treating infants with newly diagnosed acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: lestaurtinib Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807) |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Hydrocortisone acetate
Cyclophosphamide
Hydrocortisone
Prednisolone
Mercaptopurine
Prednisolone acetate
Prednisone
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Prednisolone sodium phosphate
Hydrocortisone sodium succinate
Cytarabine
Prednisolone phosphate
Hydrocortisone cypionate
Dexamethasone acetate
Leucovorin calcium
Prednisolone sodium succinate
Vincristine sulfate
Methylprednisolone sodium succinate
Dexamethasone sodium phosphate
Asparaginase
Hydrocortisone butyrate
Methotrexate sodium
Daunorubicin
Daunorubicin hydrochloride
Etoposide
Hydrocortisone valerate
Levoleucovorin
Hydrocortisone probutate
Etoposide phosphate
Pegaspargase
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival at 3 years [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dose of lestaurtinib [ Designated as safety issue: No ]
- Pharmacokinetic and pharmacodynamic profile of lestaurtinib [ Designated as safety issue: No ]
- Molecular mechanisms of resistance to lestaurtinib in leukemic blasts [ Designated as safety issue: No ]
- Levels of minimal residual disease [ Designated as safety issue: No ]
- Gene expression patterns [ Designated as safety issue: No ]
- Outcome of infants with MLL-germline ALL treated with a modified chemotherapy backbone that includes an extended continuation phase [ Designated as safety issue: No ]
| Estimated Enrollment: | 315 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | September 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Post-induction therapy A
Patients receive combination chemotherapy for up to 104 weeks.
|
Drug: asparaginase
Given IV, IM, or orally
Drug: cyclophosphamide
Given IV, IM, or orally
Drug: cytarabine
Given IT
Drug: daunorubicin hydrochloride
Given IV, IM, or orally
Drug: dexamethasone
Given IV, IM, or orally
Drug: etoposide
Given IV, IM, or orally
Drug: leucovorin calcium
Given IV, IM, or orally
Drug: mercaptopurine
Given IV, IM, or orally
Drug: methotrexate
Given IT
Drug: methylprednisolone
Given IV, IM, or orally
Drug: pegaspargase
Given IV, IM, or orally
Drug: prednisone
Given IV, IM, or orally
Drug: therapeutic hydrocortisone
Given IT
Drug: vincristine sulfate
Given IV, IM, or orally
|
|
Active Comparator: Post-induction therapy B
Patients receive a different combination chemotherapy regimen than in post-induction therapy A for up to 104 weeks.
|
Drug: asparaginase
Given IV, IM, or orally
Drug: cyclophosphamide
Given IV, IM, or orally
Drug: cytarabine
Given IT
Drug: daunorubicin hydrochloride
Given IV, IM, or orally
Drug: dexamethasone
Given IV, IM, or orally
Drug: etoposide
Given IV, IM, or orally
Drug: leucovorin calcium
Given IV, IM, or orally
Drug: mercaptopurine
Given IV, IM, or orally
Drug: methotrexate
Given IT
Drug: methylprednisolone
Given IV, IM, or orally
Drug: pegaspargase
Given IV, IM, or orally
Drug: prednisone
Given IV, IM, or orally
Drug: therapeutic hydrocortisone
Given IT
Drug: vincristine sulfate
Given IV, IM, or orally
|
|
Experimental: Post-induction therapy C
Patients receive lestaurtinib and a different combination chemotherapy regimen than in either post-induction therapy A or post-induction therapy B for up to 104 weeks.
|
Drug: asparaginase
Given IV, IM, or orally
Drug: cyclophosphamide
Given IV, IM, or orally
Drug: cytarabine
Given IT
Drug: daunorubicin hydrochloride
Given IV, IM, or orally
Drug: dexamethasone
Given IV, IM, or orally
Drug: etoposide
Given IV, IM, or orally
Drug: lestaurtinib
Given orally
Drug: leucovorin calcium
Given IV, IM, or orally
Drug: mercaptopurine
Given IV, IM, or orally
Drug: methotrexate
Given IT
Drug: methylprednisolone
Given IV, IM, or orally
Drug: pegaspargase
Given IV, IM, or orally
Drug: prednisone
Given IV, IM, or orally
Drug: therapeutic hydrocortisone
Given IT
Drug: vincristine sulfate
Given IV, IM, or orally
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
- T-cell ALL allowed
- Bilineage or biphenotypic acute leukemia allowed provided the morphology and immunophenotype are predominately lymphoid
- No mature B-cell ALL or acute myelogenous leukemia (AML)
- Must be < 366 days of age at diagnosis; neonates in the first month of life must be > 36 weeks gestational age at diagnosis
- Must be enrolled on protocol COG-AALL08B1 prior to enrollment on this protocol
Previously untreated except for the following:
Any amount of steroid pretreatment allowed, provided that the patient meets all other eligibility requirements
- Inhalation steroids are not considered as pretreatment
- Intrathecal (IT) chemotherapy (per protocol) is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid second lumbar puncture
- No B-cell ALL or acute myelogenous leukemia
PATIENT CHARACTERISTICS:
- No Down syndrome
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent chronic steroid treatment for another disease
- No other concurrent non-protocol chemotherapy or investigational therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557193
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| United States, Alabama | |
| Children's Hospital of Alabama at University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Joseph G. Pressey 205-939-9285 | |
| United States, Arizona | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016-7710 | |
| Contact: Jessica Boklan 602-546-0920 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |
| United States, California | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Amanda M. Termuhlen 562-933-8605 | |
| Southern California Permanente Medical Group | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Robert M. Cooper 323-783-5307 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048-1865 | |
| Contact: Fataneh (Fae) Majlessipour 310-423-4423 | |
| Children's Hospital Central California | Recruiting |
| Madera, California, United States, 93638-8762 | |
| Contact: Vonda L. Crouse 559-353-5480 | |
| Children's Hospital and Research Center Oakland | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: Clinical Trial Office - Children's Hospital and Research Cente 510-450-7600 | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Violet Shen 714-532-8636 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Recruiting |
| Palo Alto, California, United States, 95798 | |
| Contact: Neyssa M. Marina 650-723-5535 | |
| Kaiser Permanente Medical Center - Oakland | Recruiting |
| Sacramento, California, United States, 95661 | |
| Contact: Steven K. Bergstrom 510-752-6592 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| Rady Children's Hospital - San Diego | Recruiting |
| San Diego, California, United States, 92123-4282 | |
| Contact: Clinical Trials Office - Rady Children's Hospital - San Diego 858-966-5934 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Colorado | |
| Children's Hospital Colorado Center for Cancer and Blood Disorders | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kelly W. Maloney 720-777-6673 | |
| Presbyterian - St. Luke's Medical Center | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen 303-839-6000 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Clinical Trials Office - Connecticut Children's Medical Center 860-545-9967 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre 302-651-5755 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
| United States, Florida | |
| Lee Cancer Care of Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008 | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Eric S. Sandler 904-697-3793 | |
| Baptist-South Miami Regional Cancer Program | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Doured Daghistani 305-274-1662 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| M.D. Anderson Cancer Center at Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Vincent F. Giusti 321-841-8588 | |
| Nemours Children's Clinic - Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Ramamoorthy Nagasubramanian 407-650-7230 | |
| Nemours Children's Clinic - Pensacola | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Jeffrey H. Schwartz 850-505-4790 | |
| All Children's Hospital | Recruiting |
| Saint Petersburg, Florida, United States, 33701 | |
| Contact: Gregory A. Hale 727-767-4176 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Clinical Trials Office - St. Joseph's Cancer Institute 800-882-4123 | |
| Kaplan Cancer Center at St. Mary's Medical Center | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| Contact: Narayana Gowda 561-844-6363 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Todd M. Cooper 404-785-1838 | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Recruiting |
| Savannah, Georgia, United States, 31403-3089 | |
| Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Clinical Trials Office - Cancer Research Center of Hawaii 808-586-2979 | |
| United States, Idaho | |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Recruiting |
| Boise, Idaho, United States, 83712-6297 | |
| Contact: Eugenia Chang 208-381-2731 | |
| United States, Illinois | |
| University of Illinois Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60612-7243 | |
| Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| Children's Memorial Hospital - Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Stewart Goldman 312-227-4844 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Ammar Hayani 708-684-4094 | |
| Advocate Lutheran General Cancer Care Center | Recruiting |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care 847-384-3621 | |
| United States, Indiana | |
| Riley's Children Cancer Center at Riley Hospital for Children | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: James M. Croop 317-944-8784 | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| United States, Iowa | |
| Blank Children's Hospital | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - Blank Children's Hospital 515-241-6729 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40232 | |
| Contact: Clinical Trials Office - Kosair Children's Hospital 502-629-5500 CancerResource@nortonhealthcare.org | |
| United States, Louisiana | |
| Tulane Cancer Center Office of Clinical Research | Recruiting |
| Alexandria, Louisiana, United States, 71315-3198 | |
| Contact: Clinical Trials Office - Tulane Cancer Center 504-988-6121 | |
| Children's Hospital of New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Clinical Trials Office - Children's Hospital of New Orleans 504-894-5377 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Recruiting |
| Baltimore, Maryland, United States, 21215 | |
| Contact: Joseph M. Wiley 410-601-6266 | |
| Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| United States, Massachusetts | |
| Floating Hospital for Children at Tufts - New England Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Johannes E.A. Wolff 617-636-5535 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Contact: Clinical Trials Office - C.S. Mott Children's Hospital 800-865-1125 | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Helen DeVos Children's Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Clinical Trials Office - Helen DeVos Children's Hospital 616-391-3050 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Contact: Jeffrey S. Lobel 269-341-6350 | |
| Breslin Cancer Center at Ingham Regional Medical Center | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio 517-334-2765 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193 | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: Gail C. Megason 601-984-5220 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Recruiting |
| Columbia, Missouri, United States, 65203 | |
| Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440 | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine L. Hetherington 816-234-3265 | |
| David C. Pratt Cancer Center at St. John's Mercy | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J 314-251-6770 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89109-2306 | |
| Contact: Jonathan Bernstein 702-732-1493 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
| St. Barnabas Medical Center Cancer Center | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| Contact: Clinical Trials Office - St. Barnabas Medical Center Cancer Ce 973-322-2470 | |
| Saint Peter's University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Stanley Calderwood 732-745-6674 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Clinical Trials Office - Newark Beth Israel Medical Center 973-926-3136 | |
| St. Joseph's Hospital and Medical Center | Recruiting |
| Paterson, New Jersey, United States, 07503 | |
| Contact: Mary A. Bonilla 973-754-3349 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Recruiting |
| Summit, New Jersey, United States, 07901 | |
| Contact: Steven L. Halpern 973-971-6720 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| Albany Medical Center Hospital | Recruiting |
| Albany, New York, United States, 12208-3419 | |
| Contact: Vikramjit S. Kanwar 518-262-5513x25517 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Mark E. Weinblatt 516-663-9400 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Linda Granowetter 212-263-8400 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jeffrey R. Andolina 585-275-2981 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Mehmet F. Ozkaynak 914-493-7997 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Duke Cancer Institute | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Cancer Institute 888-275-3853 | |
| Leo W. Jenkins Cancer Center at ECU Medical School | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M 252-744-2391 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | Recruiting |
| Fargo, North Dakota, United States, 58122 | |
| Contact: Nathan L. Kobrinsky 701-234-7544 | |
| United States, Ohio | |
| Akron Children's Hospital | Recruiting |
| Akron, Ohio, United States, 44308-1062 | |
| Contact: Clinical Trials Office - Akron Children's Hospital 330-543-3193 | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106-5000 | |
| Contact: Yousif (Joe) H. Matloub 216-844-3345 | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205-2696 | |
| Contact: Laura T. Martin 614-722-3582 | |
| Dayton Children's - Dayton | Recruiting |
| Dayton, Ohio, United States, 45404-1815 | |
| Contact: Emmett H. Broxson 937-641-3111 | |
| Mercy Children's Hospital | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Rama Jasty 419-251-8215 | |
| Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Clinical Trials Office - Toledo Hospital 419-824-1842 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-5311 | |
| United States, Oregon | |
| Legacy Emanuel Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Clinical Trials Office - Legacy Emanuel Children's Hospital 503-413-2560 | |
| United States, Pennsylvania | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Penn State Children's Hospital | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Lisa M. McGregor 717-531-6012 | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Elizabeth Fox 267-425-3010 | |
| St. Christopher's Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| Contact: Clinical Trials Office - St. Christopher's Hospital for Childr 215-427-8991 | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-7056 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488 | |
| United States, South Carolina | |
| Palmetto Health South Carolina Cancer Center | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680 | |
| BI-LO Charities Children's Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Nichole L. Bryant 864-455-8898 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | Recruiting |
| Knoxville, Tennessee, United States, 37916 | |
| Contact: Ray C. Pais 865-541-8266 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| United States, Texas | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Osvaldo Regueira 806-354-5434x282 | |
| Dell Children's Medical Center of Central Texas | Recruiting |
| Austin, Texas, United States, 78723 | |
| Contact: Clinical Trials Office - Dell Children's Medical Center of Cen 512-324-8022 | |
| Driscoll Children's Hospital | Recruiting |
| Corpus Christi, Texas, United States, 78411 | |
| Contact: Clinical Trials Office - Driscoll Children's Hospital 361-694-5311 | |
| Medical City Dallas Hospital | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Carl Lenarsky 972-566-6647x4439 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| Cook Children's Medical Center - Fort Worth | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103 | |
| Baylor University Medical Center - Houston | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Patrick A. Thompson 832-824-4029 | |
| Covenant Children's Hospital | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Latha Prasannan 806-725-4840 | |
| Methodist Children's Hospital of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229-3993 | |
| Contact: Jaime Estrada 210-575-7268 | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78207 | |
| Contact: Anne-Marie R. Langevin 210-567-7477 | |
| CCOP - Scott and White Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Guy H. Grayson 254-724-2006 | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113-1100 | |
| Contact: Phillip E. Barnette 801-662-4700 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Virginia | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042-3300 | |
| Contact: Clinical Trials Office - Inova Fairfax Hospital 703-208-6650 | |
| Children's Hospital of The King's Daughters | Recruiting |
| Norfolk, Virginia, United States, 23507-1971 | |
| Contact: Eric J. Lowe 757-668-7243 | |
| United States, Washington | |
| Providence Cancer Center at Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99220-2555 | |
| Contact: Judy L. Felgenhauer 509-474-2777 | |
| Mary Bridge Children's Hospital and Health Center - Tacoma | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Robert G. Irwin 253-403-3481 | |
| Madigan Army Medical Center - Tacoma | Recruiting |
| Tacoma, Washington, United States, 98431-1100 | |
| Contact: Della L. Howell 210-916-7727 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | Recruiting |
| Charleston, West Virginia, United States, 25302 | |
| Contact: Allen R. Chauvenet 304-388-1552 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | Recruiting |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Michael E. Kelly 414-456-4170 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Catherine H. Cole 011-6189340-8238 | |
| Canada, Alberta | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Contact: Douglas R. Strother 403-955-7272 | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Sunil Jayantilal` S. Desai 780-248-5530 | |
| Canada, British Columbia | |
| Children's and Women's Hospital of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Caron Strahlendorf 604-875-3576 | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Rochelle A. Yanofsky 204-787-4163 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Contact: Lisa Anne B. Goodyear 709-777-4303 | |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| Contact: Margaret C. Yhap 902-470-8778 | |
| Canada, Ontario | |
| Children's Hospital of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Anne E.L. Cairney 519-685-8494 | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Contact: Jacqueline M.L. Halton 613-737-7600x2370 | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Sylvain Baruchel 416-813-7795 | |
| Canada, Quebec | |
| Montreal Children's Hospital at McGill University Health Center | Recruiting |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Contact: Sharon B. Abish 514-412-4400x22219 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Christopher Mpofu 306-655-2744 | |
| Israel | |
| Chaim Sheba Medical Center | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Contact: Contact Person 972-3-530-2241 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Joanne M. Hilden, MD | St. Vincent Indianapolis Hospital |
| Investigator: | Patrick A. Brown, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
Brown P, Hilden JM, Dreyer ZE, et al.: Report on excessive induction toxicity in infants with ALL enrolled on COG protocol AALL0631: A Children's Oncology Group study. [Abstract] Blood 114 (22): A-3091, 2009.
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00557193 History of Changes |
| Other Study ID Numbers: | CDR0000573996, COG-AALL0631 |
| Study First Received: | November 9, 2007 |
| Last Updated: | November 20, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
untreated childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia acute undifferentiated leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Cyclophosphamide Pegaspargase Asparaginase |
Daunorubicin Dexamethasone Etoposide Methylprednisolone Hemisuccinate Prednisolone Prednisone Vincristine BB 1101 Dexamethasone acetate Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate Methylprednisolone acetate Prednisolone acetate Hydrocortisone |
ClinicalTrials.gov processed this record on June 18, 2013