Study of Rituximab Plus High-Dose Chemotherapy Poor Prognosis 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:	NCT00141700

Purpose

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and 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 Poor-Prognosis Non-Hodgkin's Lymphoma

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

Primary Outcome Measures:

Assess progression-free survival after rituximab and high-dose chemotherapy with autologous PBPC support;

Secondary Outcome Measures:

Assess overall survival (OS) after rituximab and high-dose chemotherapy with PBPC support.
Assess safety and toxicity after rituximab and high-dose chemotherapy.
Assess CD20 recovery post-transplant

Estimated Enrollment:	30
Study Start Date:	March 2003
Study Completion Date:	December 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Combination chemotherapy is the standard treatment as initial therapy for aggressive NHL. Standard chemotherapy cures less than 40% of patients. High-dose chemotherapy with stem cell support (or transplant) is showing some positive results in patients with NHL that fail standard chemotherapy. The cure rate of this treatment is only about 50%.

Another treatment option called immunotherapy is being tested in lymphoma patients to see if adding immunotherapy to NHL treatments improves results. Rituximab, a form of immunotherapy, is an antibody (a type of protein) that attacks the CD20 protein found on lymphoma cell, which may result in the death of the lymphoma cell.

The study design is as follows: Patients with poor prognosis NHL receive rituximab as part of the peripheral blood progenitor cell mobilization process and as part of the preparative regimen in combination with high-dose chemotherapy. Granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood progenitor cells (PBPC) are collected and stored. After recovery from high-dose cyclophosphamide, patients are admitted to the hospital for transplant. The preparative regimen consists of rituximab, followed by high-dose chemotherapy.

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.
Histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas.
NHL must have high-intermediate or high International Prognostic Index (standard IPI) score at diagnosis. Mantle cell NHL is eligible regardless of IPI score.
Complete or partial response to first-line therapy.
Treated CNS or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. Patients with meningeal disease must have cytologically negative CSF at time of study entry.
Cumulative total doxorubicin: <500 mg/m2
Performance score 0-2
Patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease.
Patients must not be pregnant or nursing.
Informed Consent

Exclusion Criteria:

pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141700

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 2-51
Study First Received:	August 30, 2005
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00141700
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 13, 2009