Evaluate Rituximab in Obtaining PCR Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma

Non-Hodgkins Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00856245
• Other study ID #: 11571
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 3, 2009
• Last updated: March 31, 2015
• Start date: February 2009
• Est. completion date: January 2016

Study information

• Verified date: December 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

Intervention

Drug:
• Rituximab
375 MG/M2 given IV weekly x 4-8 doses.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kansas Medical Center, Westwood Campus	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	No