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Combination Chemotherapy in Treating Children or Adolescents With Newly Diagnosed Stage III or Stage IV Lymphoblastic Lymphoma
This study has been completed.

First Received on January 28, 2000.   Last Updated on November 20, 2010   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004228
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.

PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.


Condition Intervention Phase
Lymphoma
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival as assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival as assessed by time to death [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2000
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma*

    • Less than 25% tumor cells in the bone marrow
    • Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
    • Stage III or IV disease
  • NOTE: *Localized lymphblastic lymphoma is closed to accrual as of 10/2005

PATIENT CHARACTERISTICS:

Age:

  • 1 to 30

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • Adequate cardiac function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy

Radiotherapy:

  • Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy

Surgery:

  • Not specified

Other:

  • No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004228

  Show 176 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Minnie Abromowitch, MD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Publications:
Coustan-Smith E, Sandlund JT, Perkins SL, Chen H, Chang M, Abromowitch M, Campana D. Minimal Disseminated Disease in Childhood T-Cell Lymphoblastic Lymphoma: A Report From the Children's Oncology Group. J Clin Oncol. 2009 Jun 22; [Epub ahead of print]
Abromowitch M, Termuhlen A, Chang M, et al.: High-dose methotrexate and early intensification of therapy do not improve 3 year EFS in children and adolescents with disseminated lymphoblastic lymphoma: results of the randomized arms of COG A5971. [Abstract] Blood 112 (11): A-3610, 2008.
Smock KJ, Nelson M, Tripp SR, Sanger WG, Abromowitch M, Cairo MS, Perkins SL. Characterization of childhood precursor T-lymphoblastic lymphoma by immunophenotyping and fluorescent in situ hybridization: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Jul 10; [Epub ahead of print]
Coustan-Smith E, Abromowitz M, Sandlund JT, et al.: A novel approach for minimal residual disease detection in childhood T-cell lymphoblastic lymphoma (T-LL): a Children's Oncology Group report. [Abstract] Blood 110 (11): A-3564, 2007.

ClinicalTrials.gov Identifier: NCT00004228     History of Changes
Other Study ID Numbers: CDR0000067470, COG-A5971, CCG-59701, CCG-59701C, CCG-A5971, POG-A5971
Study First Received: January 28, 2000
Last Updated: November 20, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma

Additional relevant MeSH terms:
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Prednisone
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012