We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00856245
First Posted: March 5, 2009
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Kansas Medical Center
  Purpose
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 Intervention Phase
Non-Hodgkins Lymphoma Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 21
Study Start Date: February 2009
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rituximab
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Locations
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
Investigators
Principal Investigator: Siddhartha Ganguly, MD University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00856245     History of Changes
Other Study ID Numbers: 11571
First Submitted: March 3, 2009
First Posted: March 5, 2009
Results First Submitted: January 23, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by University of Kansas Medical Center:
non-Hodgkins
lymphoma
stem cell transplant

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