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

NCT00141700 | Terminated Phase 2

• 1 other identifier: UMCC 2-51
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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, stem cell support and Rituximab (which is a form of immunotherapy).

Conditions

Lymphoma, Non-Hodgkin's

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

Rituximab DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or nursing

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Raymond J. Hutchinson, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: March 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 10, 2008

Record last verified: 2007-12

Locations

US (1)