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

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ClinicalTrials.gov Identifier: NCT00143871
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : February 1, 2012
Sponsor:
Information provided by:
University of Michigan Cancer Center

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).

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin's Drug: Rituximab Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab Plus High-dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin's Lymphoma
Study Start Date : April 2001
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources




Primary Outcome Measures :
  1. Assess safety and toxicity after rituximab and high-dose chemotherapy

Secondary Outcome Measures :
  1. Assess CD20 depletion in leukapheresis products after rituximab and high-dose chemotherapy, and monitor CD20 recovery post-transplant
  2. 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)
  3. Assess progression-free and overall survival after rituximab and high-dose chemotherapy with PBPC support


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University of Michigan

ClinicalTrials.gov Identifier: NCT00143871     History of Changes
Other Study ID Numbers: UMCC 0074
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents