Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
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ClinicalTrials.gov Identifier: NCT00002744 |
Recruitment Status :
Completed
First Posted : September 1, 2004
Last Update Posted : February 9, 2017
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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 them in different ways may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia
PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia | Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: thioguanine Drug: vincristine sulfate Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1970 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia |
Study Start Date : | May 1996 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
Therapy defined in description.
|
Drug: asparaginase
Other Names:
Drug: cyclophosphamide Other Names:
Drug: cytarabine Other Names:
Drug: daunorubicin hydrochloride Other Name: NSC-82151 Drug: dexamethasone Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: mercaptopurine Other Names:
Drug: methotrexate Other Name: NSC-740 Drug: pegaspargase Other Names:
Drug: prednisone Other Name: NSC-10023 Drug: therapeutic hydrocortisone Drug: thioguanine Other Names:
Drug: vincristine sulfate Other Names:
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy |
Experimental: Arm 2
Therapy defined in description.
|
Drug: asparaginase
Other Names:
Drug: cyclophosphamide Other Names:
Drug: cytarabine Other Names:
Drug: daunorubicin hydrochloride Other Name: NSC-82151 Drug: dexamethasone Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: mercaptopurine Other Names:
Drug: methotrexate Other Name: NSC-740 Drug: pegaspargase Other Names:
Drug: prednisone Other Name: NSC-10023 Drug: therapeutic hydrocortisone Drug: thioguanine Other Names:
Drug: vincristine sulfate Other Names:
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy |
Experimental: Arm 3
Therapy defined in description.
|
Drug: asparaginase
Other Names:
Drug: cyclophosphamide Other Names:
Drug: cytarabine Other Names:
Drug: daunorubicin hydrochloride Other Name: NSC-82151 Drug: dexamethasone Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: mercaptopurine Other Names:
Drug: methotrexate Other Name: NSC-740 Drug: pegaspargase Other Names:
Drug: prednisone Other Name: NSC-10023 Drug: therapeutic hydrocortisone Drug: thioguanine Other Names:
Drug: vincristine sulfate Other Names:
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy |
Experimental: Arm 4
Therapy defined in description.
|
Drug: asparaginase
Other Names:
Drug: cyclophosphamide Other Names:
Drug: cytarabine Other Names:
Drug: daunorubicin hydrochloride Other Name: NSC-82151 Drug: dexamethasone Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: mercaptopurine Other Names:
Drug: methotrexate Other Name: NSC-740 Drug: pegaspargase Other Names:
Drug: prednisone Other Name: NSC-10023 Drug: therapeutic hydrocortisone Drug: thioguanine Other Names:
Drug: vincristine sulfate Other Names:
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy |
- Event Free SurvivalPrimary outcome index used in examining the randomized treatment groups will be event-free survival (EFS) from the time of randomization (i.e., end of Induction), where the life table events will consist of the first occurrence of leukemic relapse at any site, death, or occurrence of a second malignancy.
- Comparisons of CNS relapse incidence ratesComparisons of CNS relapse incidence rates for the IT MTX versus ITT groups is also planned as an important endpoint.

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Ages Eligible for Study: | 1 Year to 9 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Newly diagnosed acute lymphoblastic leukemia (ALL) obtained by bone marrow aspirate or bone marrow biopsy No greater than 25% L3 blasts Initial white blood cell count less than 50,000/mm3 (performed at CCG institution) Massive lymphadenopathy, massive splenomegaly, and/or large mediastinal mass allowed CNS or testicular leukemia allowed Allogeneic bone marrow transplant should be considered (if donor available) for patients with Philadelphia chromosome (t[9;22][q34;q11]) or translocation (4;11)(q21;q23)
PATIENT CHARACTERISTICS: Age: 1 through 9 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: No prior treatment for ALL Biologic therapy: Not specified Chemotherapy: Intrathecal cytarabine (IT ARA-C) may begin prior to registration provided systemic chemotherapy initiated within 72 hours after IT ARA-C Endocrine therapy: See Radiotherapy At least 1 month since prior systemic steroids Steroids given for less than 48 hours allowed Inhaled corticosteroids allowed at any time Radiotherapy: Radiotherapy or dexamethasone for mediastinal mass causing superior mediastinal syndrome allowed prior to registration, if indicated 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): NCT00002744

Study Chair: | Linda C. Stork, MD | Doernbecher Children's Hospital at Oregon Health and Science University |
Other Publications:
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00002744 |
Other Study ID Numbers: |
1952 CCG-1952 CDR0000064665 ( Other Identifier: Clinical Trials.gov ) |
First Posted: | September 1, 2004 Key Record Dates |
Last Update Posted: | February 9, 2017 |
Last Verified: | July 2014 |
untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 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 Cobalt Cytarabine Dexamethasone Prednisone Hydrocortisone Hydrocortisone 17-butyrate 21-propionate |
Hydrocortisone acetate Hydrocortisone hemisuccinate Cyclophosphamide Doxorubicin Liposomal doxorubicin Methotrexate Vincristine Daunorubicin Asparaginase Mercaptopurine Pegaspargase Thioguanine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |