Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin’s Lymphoma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 31, 2005

Last Updated Date

April 2, 2007

Start Date ^†

April 2001

Current Primary Outcome Measures ^†

Assess safety and toxicity after rituximab and high-dose chemotherapy

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00143871 on ClinicalTrials.gov Archive Site

Current 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Rituximab Plus High-Dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin’s Lymphoma

Brief Summary

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).

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Lymphoma, Non-Hodgkin's

Intervention ^†

Drug: Rituximab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00143871

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Michigan Cancer Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Raymond J. Hutchinson, MD

The University of Michigan

Information Provided By

University of Michigan Cancer Center

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.