Rituximab Plus High-Dose Chemotherapy With Autologous Stem Cell Support for Poor-Prognosis Non-Hodgkin's Lymphoma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess progression-free survival after rituximab and high-dose chemotherapy with autologous PBPC support;
Raymond J. Hutchinson, MD
Principal Investigator
University of Michigan
United States: Institutional Review Board
UMCC 2-51
NCT00141700
March 2003
December 2005
Name | Location |
---|---|
The University of Michigan | Ann Arbor, Michigan 48109 |