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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00040690
First received: July 8, 2002
Last updated: December 18, 2013
Last verified: May 2007
  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: 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 [ Designated as safety issue: No ]

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

Estimated Enrollment: 120
Study Start Date: November 2008
Study Completion Date: December 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
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: 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00040690     History of Changes
Other Study ID Numbers: CDR0000069374, MRC-LY10, EU-20117
Study First Received: July 8, 2002
Last Updated: December 18, 2013
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:
Burkitt Lymphoma
Leukemia
Lymphoma
DNA Virus Infections
Epstein-Barr Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Experimental
Tumor Virus Infections
Virus Diseases
Cyclophosphamide
Doxorubicin
Levoleucovorin
Liposomal doxorubicin
Methotrexate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antibiotics, Antineoplastic
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on October 21, 2014