Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
|ClinicalTrials.gov Identifier: NCT00856245|
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkins Lymphoma||Drug: Rituximab||Phase 2|
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 transplantation. One of the common causes of relapse is persistence of lymphoma cells in the bone marrow and in the collected stem cell products.
Patients who do not have a complete response after traditional chemotherapy, have a greater chance of the lymphoma returning even after receiving high dose chemotherapy with stem cell transplantation. In order to improve the response and decrease the relapse rate, additional therapy may be used to kill the lymphoma cells by using antibodies both before and after the transplantation. Antibodies are protein made by white cells in our body to fight off infection and sometimes tumor. Rituxan (rituximab) is an antibody that is effective against your type of lymphoma. Researchers have reported that patients show an improved response and a lower chance of relapse when using rituximab with high dose chemotherapy with autologous stem cell transplantation. It is unknown how effective rituximab is in clearing persistence of minimal remaining disease in patients with follicular lymphoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Rituximab Containing Salvage Chemotherapy and in Vivo Purging in Obtaining PCR Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma or Transplant Eligible Mantle Cell Lymphoma|
|Study Start Date :||February 2009|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
Patients will be treated IV with rituximab at the rate of 50 milligrams per hour (mg/hour) for 1 hour. If patient tolerates the infusion, the rate is increased by increments of 50 mg/hour every 30 minutes to a maximum of 400 mg/hour. If patient has a severe reaction, the infusion is stopped temporarily and the infusion rate is decreased by 50%. Subsequent infusions are started at the rate of 100 mg/hour, increased by 100 mg/hour every 30 minutes to a maximum of 400 mg/hour if tolerated. Vital signs are monitored every 15 minutes for 2 hours and every 30 minutes thereafter.
375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
Other Name: Rituxan
- Rate of PCR Negativity [ Time Frame: up to 7 days ]Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.
- Progression Free Survival (PFS) and Overall Survival (OS) [ Time Frame: up to 60 months ]Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856245
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|University of Kansas Medical Center, Westwood Campus|
|Kansas City, Kansas, United States, 66205|
|Principal Investigator:||Siddhartha Ganguly, MD||University of Kansas Medical Center|