Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia
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| ClinicalTrials.gov Identifier: NCT00005945 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : February 23, 2016
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating childhood acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is comparing different combination chemotherapy regimens to see how well they work in treating children with acute lymphoblastic leukemia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia | Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3054 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Escalating Dose Intravenous Methotrexate Without Leucovorin Rescue Versus Oral Methotrexate and Single Versus Double Delayed Intensification for Children With Standard Risk Acute Lymphoblastic Leukemia |
| Study Start Date : | June 2000 |
| Actual Primary Completion Date : | November 2007 |
| Actual Study Completion Date : | June 2008 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Induction Not Randomized
Standard Induction (28 Days). M3 Marrow at Day 28 and Off Protocol Therapy.
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Drug: cyclophosphamide
Given IV
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: methotrexate Given PO and IT
Other Name: MTX Drug: pegaspargase Given IM
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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Experimental: Induction and Oral MTX, Double Delayed Intensification CNS
Patients with CNS disease at diagnosis, without other unfavorable characteristics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Cranial radiation therapy during the Consolidation phase.
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Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine Given IT
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: doxorubicin hydrochloride Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Other Names:
Drug: mercaptopurine Given PO
Other Name: 6-MP Drug: methotrexate Given PO and IT
Other Name: MTX Drug: pegaspargase Given IM
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
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Experimental: Induction and Augmented regimen (IV MTX, Double DI)
Patients with unfavorable characteristics. Standard Induction (14 Days), Augmented Induction (Days 14-35), Consolidation (9 weeks), Interim Maintenance I (56 Days), Delayed Intensification I (2 months), Interim Maintenance II (2 months), Delayed Intensification II (2 months), then Maintenance (84 day courses).
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Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine Given IT
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: doxorubicin hydrochloride Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Other Names:
Drug: mercaptopurine Given PO
Other Name: 6-MP Drug: methotrexate Given PO and IT
Other Name: MTX Drug: pegaspargase Given IM
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
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Experimental: Induction and Oral MTX, Single Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months) then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
|
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine Given IT
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: doxorubicin hydrochloride Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Other Names:
Drug: mercaptopurine Given PO
Other Name: 6-MP Drug: methotrexate Given PO and IT
Other Name: MTX Drug: pegaspargase Given IM
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
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|
Experimental: Induction and Oral MTX, Double Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
|
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine Given IT
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: doxorubicin hydrochloride Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Other Names:
Drug: mercaptopurine Given PO
Other Name: 6-MP Drug: methotrexate Given PO and IT
Other Name: MTX Drug: pegaspargase Given IM
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
|
|
Experimental: Induction and IV MTX, Single Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months) then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
|
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine Given IT
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: doxorubicin hydrochloride Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Other Names:
Drug: mercaptopurine Given PO
Other Name: 6-MP Drug: methotrexate Given PO and IT
Other Name: MTX Drug: pegaspargase Given IM
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
|
|
Experimental: Induction and IV MTX, Double Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in event free remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
|
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine Given IT
Other Names:
Drug: dexamethasone Given PO
Other Names:
Drug: doxorubicin hydrochloride Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Other Names:
Drug: mercaptopurine Given PO
Other Name: 6-MP Drug: methotrexate Given PO and IT
Other Name: MTX Drug: pegaspargase Given IM
Other Names:
Drug: thioguanine Given PO
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy Undergo radiation therapy
Other Names:
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Primary Outcome Measures :
- Event Free Survival [ Time Frame: Time of randomization ]The primary outcome index used in examining the randomized treatment groups will be event free survival (EFS) from the time of randomization (i.e., end of Consolidation), where the life table events will consist of the first occurrence of leukemic relapse at any site, death, or occurrence of a second malignancy.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 1 Year to 9 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of previously untreated B-cell precursor acute lymphoblastic leukemia
- More than 25% L1 or L2 lymphoblasts
- No more than 25% L3 lymphoblasts
- WBC < 50,000/mm^3
- No T-cell precursor acute lymphoblastic leukemia by immunophenotyping
- Massive lymphadenopathy, massive splenomegaly, or large mediastinal mass allowed
- CNS or testicular leukemia allowed
- No patients found to have t(8;14)(q24;q32), t(8;22)(q24;q11), and t(2;8)(p11-p12;q24) (characteristic of Burkitt's lymphoma)
PATIENT CHARACTERISTICS:
Age:
- 1 to 9
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 72 hours since prior intrathecal cytarabine
Endocrine therapy:
- At least 30 days since prior systemic corticosteroids given for more than 48 hours
- Prior corticosteroids for mediastinal mass causing superior mediastinal syndrome allowed
- Prior or concurrent inhaled corticosteroids allowed
Radiotherapy:
- Prior radiotherapy for mediastinal mass causing superior mediastinal syndrome allowed
- No concurrent spinal radiotherapy
Surgery:
- Not specified
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): NCT00005945
Show 130 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | Yousif H. Matloub, MD | University of Wisconsin, Madison |
Publications of Results:
Matloub Y, Bostrom BC, Angiolillo AL, et al.: Children with NCI standard risk acute lymphoblastic leukemia (ALL) and TEL-AML1 or favorable chromosome trisomies are almost certain to be cured with graduated intensity therapy: results of the CCG - 1991 study. [Abstract] Blood 114 (22): A-320, 2009.
Matloub Y, Bostrom BC, Hunger SP, et al.: Escalating dose intravenous methotrexate without leucovorin rescue during interim maintenance is superior to oral methotrexate for children with standard risk acute lymphoblastic leukemia (SR-ALL): Children's Oncology Group study 1991. [Abstract] Blood 112 (11): A-9, 2008.
Matloub Y, Angiolillo A, Bostrom B, et al.: Double delayed intensification (DDI) is equivalent to single DI (SDI) in children with National Cancer Institute (NCI) standard-risk acute lymphoblastic leukemia (SR-ALL) treated on Children's Cancer Group (CCG) clinical trial 1991 (CCG-1991). [Abstract] Blood 108 (11): A-146, 2006.
Other Publications:
Bruggers CS, Moyer-Mileur LJ, Ransdall L: Body composition, bone mineral acquisition, and cardiovascular fitness in children with standard risk acute lymphoblastic leukemia: response to a home-based exercise and nutrition education program. [Abstract] 2006 Pediatric Academic Societies' Annual Meeting, April 29 - May 2, San Francisco, CA. A-3505.46, 2006.
Matloub Y, Asselin BL, Stork LC, et al.: Outcome of children with T-Cell acute lymphoblastic leukemia (T-ALL) and standard risk (SR) features: results of CCG-1952, CCG-1991 and POG 9404. [Abstract] Blood 104 (11): A-680, 195a, 2004.
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00005945 History of Changes |
| Other Study ID Numbers: |
1991 CCG-1991 ( Other Identifier: Children's Cancer Group ) CDR0000067855 ( Other Identifier: Clinical Trials.gov ) NCI-2012-02333 ( Other Identifier: NCI ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | February 23, 2016 |
| Last Verified: | February 2016 |
Keywords provided by Children's Oncology Group:
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untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia L3 childhood acute lymphoblastic leukemia |
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 Liposomal doxorubicin Pegaspargase Cyclophosphamide Doxorubicin Methotrexate |
Cytarabine Vincristine Daunorubicin Asparaginase 6-Mercaptopurine Thioguanine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |