This trial is active, not recruiting.

Condition non-hodgkins lymphoma
Treatment rituximab
Phase phase 2
Target CD20
Sponsor University of Kansas
Start date February 2009
End date September 2015
Trial size 21 participants
Trial identifier NCT00856245, 11571


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 collections.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients will be treated IV with rituximab at the rate of 50 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.
rituximab Rituxan
375 MG/M2 given IV weekly x 4-8 doses.

Primary Outcomes

To determine the role of Rituximab containing salvage regimens in achieving BCL2 PCR negative stem cell harvest product in patients with relapsed CD20+ follicular lymphoma or transplant eligible mantle cell lymphoma.
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with biopsy-proven refractory CD20+ Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 or later. - Patients must be transplant eligible per KUCC BMT SOP with chemo-sensitive/marrow negative disease. - Patients planning to harvest and hold may also be included as long as above criteria are met. Exclusion Criteria: - 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 greater than 3 times upper limit of normal - Evidence of chronic active hepatitis or cirrhosis - Unable to sign informed consent. - Allergy to Rituximab

Additional Information

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
Principal investigator Siddhartha Ganguly, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Kansas.