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Combination Chemotherapy in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00040690
First Posted: January 27, 2003
Last Update Posted: December 19, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  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 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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

Secondary Outcome Measures:
  • Survival time

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00040690


Locations
United Kingdom
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

Publications:
ClinicalTrials.gov Identifier: NCT00040690     History of Changes
Other Study ID Numbers: CDR0000069374
MRC-LY10
EU-20117
First Submitted: July 8, 2002
First Posted: January 27, 2003
Last Update Posted: December 19, 2013
Last Verified: May 2007

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:
Lymphoma
Leukemia
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Cyclophosphamide
Methotrexate
Cytarabine
Ifosfamide
Liposomal doxorubicin
Doxorubicin
Etoposide
Vincristine
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating


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