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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00856245
First received: March 3, 2009
Last updated: December 30, 2013
Last verified: December 2013
  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: 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:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: February 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rituximab
Patients will be treated IV with rituximab at the rate of 50 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 given IV 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856245

Locations
United States, Kansas
University of Kansas Medical Center, Westwood Campus
Kansas City, Kansas, United States, 66205
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Siddhartha Ganguly, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00856245     History of Changes
Other Study ID Numbers: 11571
Study First Received: March 3, 2009
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014