Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002812 |
Recruitment Status :
Completed
First Posted : November 24, 2003
Last Update Posted : August 26, 2013
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia | Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2078 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study |
Study Start Date : | September 1996 |
Actual Primary Completion Date : | March 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A - Standard BFM of Standard Duration (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow. Consolidation (Phase II) (5 weeks) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
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Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
Experimental: Arm B - Standard BFM with Double Delayed Intensification (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (5 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
|
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
Experimental: Arm C - Augumented BFM of Standard Duration (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
|
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
Experimental: Arm D - Augmented BFM with Dbl Delayed Intensification (RER)
Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
|
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: idarubicin Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given PO
Other Name: NSC-740 Drug: pegaspargase Given IV
Other Names:
Drug: prednisone Given PO
Other Name: NSC-10023 Drug: thioguanine Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Radiation: radiation therapy |
- Event Free Survival [ Time Frame: from the time of randomization where the life table events will consist of the first occurrence of the following events: failure to achieve remission, leukemic relapse at any site, death, or occurrence of a second malignancy. ]The primary outcome index used in examining most of the randomized treatment groups will be event-free survival (EFS).

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Ages Eligible for Study: | 1 Year to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Acute lymphocytic leukemia (ALL) with M3 bone marrow No FAB L3 morphology CNS or overt testicular leukemia at diagnosis allowed High risk status 10-21 years old with any white blood count (WBC) 1-9 years old with WBC of 50,000/mm3 or greater
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: No prior therapy for ALL except: Emergency therapy for blast crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration Biologic therapy: Not specified Chemotherapy: Intrathecal cytarabine or methotrexate allowed at diagnostic lumbar puncture Induction therapy must begin within 72 hours after intrathecal injection Endocrine therapy: At least 1-2 months since prior prednisone, for less than 48 hours, for reactive airway disease Inhalational steroids allowed Radiotherapy: Not specified 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): NCT00002812

Study Chair: | Nita L. Seibel, MD | Children's National Research Institute |
Other Publications:
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00002812 |
Other Study ID Numbers: |
1961 CCG-1961 ( Other Identifier: Children's Cancer Group ) CDR0000064953 ( Other Identifier: Clinical Trials.gov ) |
First Posted: | November 24, 2003 Key Record Dates |
Last Update Posted: | August 26, 2013 |
Last Verified: | August 2013 |
untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Prednisone Cyclophosphamide Doxorubicin Liposomal doxorubicin |
Methotrexate Vincristine Daunorubicin Asparaginase Mercaptopurine Idarubicin Pegaspargase Thioguanine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |