Study of Rituximab Plus High-Dose Chemotherapy Poor Prognosis Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00141700|
Recruitment Status : Terminated (enrollment completed)
First Posted : September 1, 2005
Last Update Posted : January 10, 2008
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin's||Drug: Rituximab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rituximab Plus High-Dose Chemotherapy With Autologous Stem Cell Support for Poor-Prognosis Non-Hodgkin's Lymphoma|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||December 2005|
- Assess progression-free survival after rituximab and high-dose chemotherapy with autologous PBPC support;
- 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
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): NCT00141700
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Raymond J. Hutchinson, MD||University of Michigan|