Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00005945 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : February 23, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: Induction Not Randomized
Standard Induction (28 Days). M3 Marrow at Day 28 and Off Protocol Therapy.
|
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:
|
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.
|
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 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).
|
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:
|
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:
|
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:
|
- 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.

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 9 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
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

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

Study Chair: | Yousif H. Matloub, MD | University of Wisconsin, Madison |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00005945 |
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 |
untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia L3 childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Cyclophosphamide Doxorubicin Liposomal doxorubicin Methotrexate |
Vincristine Daunorubicin Asparaginase Mercaptopurine Pegaspargase Thioguanine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |