Treatment of Burkitt Lymphoma/Leukemia and B Large Cell NHL

This study has been completed.
Sponsor:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187161
First received: September 13, 2005
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

This is a pilot study to demonstrate that the modified LMB-89 treatment regimen for children with newly diagnosed small noncleaved cell NHL, large cell NHL (B-cell), and B-cell acute lymphoblastic leukemia can be delivered in this setting with acceptable toxicity.


Condition Intervention Phase
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia, Mature B-Cell
Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Small Noncleaved Cell (SNCC), Non-Hodgkin Lymphoma (NHL), Large Cell NHL (B-Cell) and B-Cell Acute Lymphoblastic Leukemia (B-ALL) Study II

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • The purpose of this study is estimate the complete response, event-free survival, and overall survival in patients with small non-cleaved cell non-Hodgkin lymphoma or large cell NHL, or Burkitt leukemia/B-cell ALL treated with a modified LMP-89 regimen. [ Time Frame: 8-9 years ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: November 1994
Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: A

Group A: Resected Stage I and resected abdominal Stage II

Subjects will receive two courses (3 weeks apart) of COPAD.

Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
The additional information is contained in the Detailed Description section.
Experimental: B

Group B: Other Stage II, Stage III, Stage IV or B-ALL M blast <70%; no CNS involvement.

Subjects in Group B will receive one week of treatment of COP.

Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
The additional information is contained in the Detailed Description section.
Experimental: C

Group C: B-ALL with >70% BM blasts; CNS involvement, Group B COP failures i.e., <20% reduction Treatment Pre-Induction

Subjects will receive one week of treatment of COP.

Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
The additional information is contained in the Detailed Description section.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be previously untreated, except for steroids.
  • Subject must be less than or equal to 18 years of age.
  • Subject must have a histologic diagnosis of small noncleaved cell (SNCC) NHL or large cell NHL (B-cell), or B-cell acute lymphocytic leukemia.

Exclusion Criteria:

  • Previously treated disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187161

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: John T. Sandlund, M.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: John T. Sandlund, MD / Principal Investigator, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187161     History of Changes
Other Study ID Numbers: SJBCII
Study First Received: September 13, 2005
Last Updated: June 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Mature B-Cell Leukemia
Non-Hodgkin Lymphoma
Burkitt's lymphoma
Small noncleaved cell non Hodgkin lymphoma
Large cell lymphoma

Additional relevant MeSH terms:
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Doxorubicin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014