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

NCT00143871 | Completed Phase 2 DMC

• 1 other identifier: UMCC 0074
• Study Type: interventional
• Target: 35
• 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, plus the addition of Rituximab (which is a form of immunotherapy).

Conditions

Lymphoma, Non-Hodgkin's

Outcome Measures

Primary Outcomes (1)

• Assess safety and toxicity after rituximab and high-dose chemotherapy

Secondary Outcomes (3)

• 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

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.
• 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

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 31, 2005
• First Posted: September 2, 2005
• Study Start: April 1, 2001
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

US (1)