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Combination Chemotherapy in Treating Children With Newly Diagnosed 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: NCT00002744
Recruitment Status : Completed
First Posted : September 1, 2004
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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

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Layout table for study information
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:
  • 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



Primary Outcome Measures :
  1. Event Free Survival
    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 :
  1. Comparisons of CNS relapse incidence rates
    Comparisons of CNS relapse incidence rates for the IT MTX versus ITT groups is also planned as an important endpoint.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
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


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): NCT00002744


Locations
Show Show 34 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Linda C. Stork, MD Doernbecher Children's Hospital at Oregon Health and Science University
Publications of Results:
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.

Other Publications:
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.

Layout table for additonal information
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
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:
Layout table for MeSH terms
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