Status:
COMPLETED
Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell transplantation will help patients get rid of their lymphoma cells from the bone marrow and stem cell collec...
Detailed Description
Following the first relapse, patients with follicular type of Non-Hodgkin's lymphoma may have an option to receive high dose chemotherapy followed by autologous (from you) blood stem cell transplantat...
Eligibility Criteria
Inclusion
- Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20) Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete remission 1) or later.
- Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow negative disease.
- Patients planning to harvest and hold may also be included as long as above criteria are met.
Exclusion
- Pregnancy
- Zubrod performance status greater than 2
- Life expectancy is severely limited by concomitant illness.
- Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
- Symptomatic pulmonary disease precluding transplantation
- Serum creatinine greater than 1.8 mg/dL
- Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate transaminase) greater than 3 times upper limit of normal
- Evidence of chronic active hepatitis or cirrhosis
- Unable to sign informed consent.
- Allergy to Rituximab
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00856245
Start Date
February 1 2009
End Date
July 1 2015
Last Update
May 30 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
University of Kansas Medical Center, Westwood Campus
Kansas City, Kansas, United States, 66205