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

Sponsored by:	University of Michigan Cancer Center
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00143871

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 II

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Rituximab Plus High-Dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin’s Lymphoma

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

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

The University of Michigan

More Information

Study ID Numbers:	UMCC 0074
Study First Received:	August 31, 2005
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00143871
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009