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Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00002744
First received: November 1, 1999
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event Free Survival [ Designated as safety issue: No ]
    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 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.


Secondary Outcome Measures:
  • Comparisons of CNS relapse incidence rates [ Designated as safety issue: No ]
    Comparisons of CNS relapse incidence rates for the IT MTX versus ITT groups is also planned as an important endpoint.


Enrollment: 1970
Study Start Date: May 1996
Study Completion Date: March 2007
Primary Completion Date: February 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977
Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.
Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U
Drug: daunorubicin hydrochloride
Other Name: NSC-82151
Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521
Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127
Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol
Drug: methotrexate
Other Name: NSC-740
Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®
Drug: prednisone
Other Name: NSC-10023
Drug: therapeutic hydrocortisone Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752
Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy
Experimental: Arm 2
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977
Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.
Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U
Drug: daunorubicin hydrochloride
Other Name: NSC-82151
Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521
Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127
Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol
Drug: methotrexate
Other Name: NSC-740
Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®
Drug: prednisone
Other Name: NSC-10023
Drug: therapeutic hydrocortisone Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752
Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy
Experimental: Arm 3
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977
Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.
Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U
Drug: daunorubicin hydrochloride
Other Name: NSC-82151
Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521
Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127
Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol
Drug: methotrexate
Other Name: NSC-740
Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®
Drug: prednisone
Other Name: NSC-10023
Drug: therapeutic hydrocortisone Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752
Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy
Experimental: Arm 4
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977
Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.
Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U
Drug: daunorubicin hydrochloride
Other Name: NSC-82151
Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521
Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127
Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol
Drug: methotrexate
Other Name: NSC-740
Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®
Drug: prednisone
Other Name: NSC-10023
Drug: therapeutic hydrocortisone Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752
Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574
Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002744

  Show 34 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Linda C. Stork, MD Doernbecher Children's Hospital at Oregon Health and Science University
  More Information

Additional Information:
Publications:
Malempati S, Gaynon PS, Sather H, et al.: Outcome after relapse among children with standard risk (SR) ALL treated on CCG-1952. [Abstract] Blood 104 (11): A-520, 2004.
Stork LC, Sather H, Hutchinson RJ, et al.: Comparison of mercaptopurine (MP) with thioguanine (TG) and IT methotrexate (ITM) with IT "triples" (ITT) in children with SR-ALL: results of CCG-1952. [Abstract] Blood 100 (11 Pt 1): A-585, 156a, 2002.
Stork LC, Sather H, Yanofsky R, et al.: Hyperdiploidy with trisomy 10 and TEL-AML1 expression among children with standard risk acute lymphoblastic leukemia (SR-ALL): a CCG-1952 report. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1476, 2001.
Gaynon PS, Stork L, Sather H, et al.: Leukemic progenitor cell content of pre- and post-induction chemotherapy bone marrow specimens from children with newly diagnosed or relapsed acute lymphoblastic leukemia (ALL). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-2187, 567a, 1999.
Stork LC, Erdmann G, Adamson P, et al.: Oral 6-thioguanine causes relatively mild and reversible hepatic veno-occlusive disease(VOD). J Pediatr Hematol Oncol 20: 400a, 1998.
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: NCT00002744     History of Changes
Other Study ID Numbers: 1952, CCG-1952, CDR0000064665
Study First Received: November 1, 1999
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia
L1 childhood acute lymphoblastic leukemia
L2 childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
6-Mercaptopurine
Asparaginase
Cortisol succinate
Cyclophosphamide
Daunorubicin
Dexamethasone
Doxorubicin
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Liposomal doxorubicin
Methotrexate
Pegaspargase
Thioguanine
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on November 20, 2014