Non Hodgkin Lymphoma Clinical Trial

Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

21

Study ID:

NCT00856245

Recruitment Status:

Completed

Sponsor:

University of Kansas Medical Center

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There are 2 Locations for this study

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University of Kansas Medical Center
Kansas City Kansas, 66160, United States
University of Kansas Medical Center, Westwood Campus
Kansas City Kansas, 66205, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

21

Study ID:

NCT00856245

Recruitment Status:

Completed

Sponsor:


University of Kansas Medical Center

How clear is this clinincal trial information?

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