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Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00143871
First received: August 31, 2005
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, plus the addition of Rituximab (which is a form of immunotherapy).


Condition Intervention Phase
Lymphoma, Non-Hodgkin's
 Drug: Rituximab
 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: Rituximab Plus High-dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Assess safety and toxicity after rituximab and high-dose chemotherapy

Secondary Outcome Measures:
  • Assess CD20 depletion in leukapheresis products after rituximab and high-dose chemotherapy, and monitor CD20 recovery post-transplant
  • Assess the response rate after rituximab and high-dose chemotherapy with autologous peripheral blood progenitor cell (PBPC) support, for patients with relapsed CD20+ Non-Hodgkin's lymphoma (NHL)
  • Assess progression-free and overall survival after rituximab and high-dose chemotherapy with PBPC support

Estimated Enrollment: 35
Study Start Date: April 2001
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Combination chemotherapy is the standard treatment as initial therapy for advanced stage aggressive Non-Hodgkin's lymphoma (NHL). Standard chemotherapy cures less than 40% of patients. When patients relapse, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Multiple studies have shown the value of high-dose chemotherapy, with increased disease-free survival and overall survival, when compared with second-line conventional chemotherapy. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it, and other treatment strategies are needed to improve the cure rate.

Another treatment option called immunotherapy is being tested in lymphoma patients. Immunotherapy involves attempts to use the immune system or products of the immune system to fight lymphoma. For example, NHL cells have a protein called CD20 on their surface. Rituximab is an antibody directed against the CD20 protein, which may result in the death of the lymphoma cell. Patients in this study will receive Rituximab to see if it is a safe treatment option for NHL patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented, aggressive and/ or intermediate grade and high-grade B cell NHL, CD20 positive.
  • In relapse after primary conventional chemotherapy
  • Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse
  • Treatment of CNS or meningeal disease (cytology-negative CSF) if present
  • Treatment of CNS or meningeal disease (cytology-negative CSF) if present.
  • Cumulative total doxorubicin dosage <500 mg/m2
  • Performance score: 0-2
  • Prior malignancies eligible if treated for cure and without active disease
  • Patients must not be pregnant or nursing.
  • Prior Immunotherapy is allowed
  • Signed Informed Consent
  • Absolute neutrophil count > 1500/ µl, platelet count >100,000/ µl
  • Bilirubin <1.5 x normal, SGOT <2.5 x normal
  • Serum creatinine <1.5 mg/dl
  • Ejection fraction > 45% or > 40% with normal wall motion
  • HIV negative
  • FEV1, DLCO > 50% predicted

Exclusion Criteria:

  • Pregnant or nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143871

Locations
United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Raymond J. Hutchinson, MD University of Michigan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00143871     History of Changes
Other Study ID Numbers: UMCC 0074
Study First Received: August 31, 2005
Last Updated: January 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013