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

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ClinicalTrials.gov Identifier: NCT00856245
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkins Lymphoma Drug: Rituximab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Rituximab
375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
Other Name: Rituxan

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
University of Kansas Medical Center
Principal Investigator: Siddhartha Ganguly, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00856245     History of Changes
Other Study ID Numbers: 11571
First Posted: March 5, 2009    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by University of Kansas Medical Center:
stem cell transplant

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents