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

January 30, 2012 updated by: University of Michigan Rogel Cancer Center

Rituximab Plus High-dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin's Lymphoma

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess safety and toxicity after rituximab and high-dose chemotherapy

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Raymond J. Hutchinson, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 0074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe