We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov Menu

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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 2, 2005
Last Update Posted: February 1, 2012
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:
University of Michigan Cancer Center
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
Intervention Model: Single Group Assignment
Masking: None (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:

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.


Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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): NCT00143871

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

ClinicalTrials.gov Identifier: NCT00143871     History of Changes
Other Study ID Numbers: UMCC 0074
First Submitted: August 31, 2005
First Posted: September 2, 2005
Last Update Posted: February 1, 2012
Last Verified: January 2012

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