Clinical trial NCT00856245: Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkins Lymphoma
Keywords: non-Hodgkins
lymphoma
stem cell transplant
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-03-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 collections.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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 (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

Primary outcomes:
measure: Rate of PCR Negativity
timeFrame: up to 7 days
Secondary outcomes:
measure: Progression Free Survival (PFS) and Overall Survival (OS)
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Westwood Campus
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Siddhartha Ganguly, MD
role: PRINCIPAL_INVESTIGATOR
References: