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Combination Chemotherapy in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
This study is ongoing, but not recruiting participants.
First Received: July 8, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040690
  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 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.


Condition Intervention Phase
Leukemia
Lymphoma
Biological: filgrastim
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Clinicopathological Study In Burkitts's And Burkitt-Like Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of diffuse B-cell lymphoma in a nodal or an extranodal site

    • CD20 and CD79 positive
    • 100% expression of Ki67 (MIB1) in all of the tumor cells OR
  • Diagnosis of bone marrow replacement/leukemia comprising mature B-cell lymphoma

    • sIg and CD19 positive
    • CD34 and Tdt negative
  • Patients in the low-risk group must meet at least 3 of the following criteria:

    • Normal lactate dehydrogenase (LDH) level
    • WHO performance status 0-1
    • Ann Arbor stage I or II
    • No more than 1 extranodal site (e.g., bone marrow, gastrointestinal tract, or CNS)
  • Patients in the high-risk group must meet at least 2 of the following criteria:

    • Raised LDH level
    • WHO performance status 2-4
    • Ann Arbor stage III or IV
    • More than 1 extranodal site

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • See Disease Characteristics

Renal:

  • Not specified

Other:

  • No mental or physical status that would preclude study
  • No other disease or prior malignancy that would preclude study
  • HIV negative
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy except 1 course of preinduction chemotherapy (e.g., CHOP [cyclophosphamide, doxorubicin, vincristine, and prednisone] or a related regimen)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040690

Locations
United Kingdom, England
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Simon Clawson Medical Research Council
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069374, MRC-LY10, EU-20117
Study First Received: July 8, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00040690     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated adult acute lymphoblastic leukemia
L3 adult acute lymphoblastic leukemia
stage I adult Burkitt lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult Burkitt lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neoplasms, Experimental
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Immunoproliferative Disorders
Immune System Diseases
Vincristine
Abortifacient Agents, Nonsteroidal
Doxorubicin
Herpesviridae Infections
Virus Diseases
Neoplasms
DNA Virus Infections
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites
Immunologic Factors
Antineoplastic Agents
Tumor Virus Infections
Leucovorin
Cyclophosphamide
Reproductive Control Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on November 05, 2009