search
Back to results

Peripheral Blood Stem Cell (PBSC) Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine

Primary Purpose

Lymphoma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Bendamustine
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring non-Hodgkin's lymphoma, autologous stem cell transplant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with relapsed or refractory C20+ non-Hodgkin's lymphoma (proven by biopsy, radiological findings or clinical exam) referred to BMT clinic of Kansas University Medical Center for consideration of autologous stem cell transplantation. No separate recruitment method or advertisement will be used to enroll patients.
  • Age 18-70 years.

Exclusion Criteria:

  • Pregnancy and nursing mother
  • Karnofsky performance status less than 50%
  • 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 times 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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

rituximab

bendamustine

Arm Description

bendamustine, 90 mg/M2

Outcomes

Primary Outcome Measures

To assess the efficacy of G-CSF induced PBSC mobilization after two cycles of rituximab and Bendamustine (BR) as salvage therapy in patients with relapsed non-Hodgkins lymphoma

Secondary Outcome Measures

Full Information

First Posted
November 25, 2009
Last Updated
January 6, 2017
Sponsor
University of Kansas Medical Center
Collaborators
Cephalon
search

1. Study Identification

Unique Protocol Identification Number
NCT01022021
Brief Title
Peripheral Blood Stem Cell (PBSC) Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine
Official Title
Adequacy of Peripheral Blood Stem Cell Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine: A Pilot Project and a Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Cephalon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with certain types of cancer require treatment with very high doses of chemotherapy. A side effect of high chemotherapy doses is damage to the bone marrow where our blood and immune system cells are produced. Stem cells (or progenitor cells) are the source of all blood cells. They are formed in the bone marrow (the spongy cavity in the center of large bones). The stem cells receive signals that direct them to become red cells, white cells or platelets. This happens before they are released into the blood stream. Stem cells circulating in the blood stream can be collected through a process called "apheresis" or "stem cell collection". The cells are then processed and frozen to preserve them. After chemotherapy has been given the stem cells are thawed and given back intravenously (IV: into the vein), like a blood transfusion. The stem cells in the collection will find their way back into the bone marrow space and, after a few days, will start to produce the blood and immune cells as they normally would. Having your own stem cells collected and returned to you later is called an "autologous transplant." Non-Hodgkin's lymphoma is a disease in which malignant cancer cells form in the lymph system. Autologous stem cell transplantation is the standard of care for a chemo-sensitive relapse in patients with large cell lymphoma that has spread. Bendamustine works by blocking the growth of cancer cells. It is used for the management of chronic lymphocytic leukemia and follicular lymphoma. Bendamustine in addition to rituximab (BR) is used in several trials in patients with lymphoma with encouraging results. Adequate peripheral blood stem cell (PBSC) collection is a pre-requisite for high dose therapy followed by cell transplantation in patients with relapsed lymphoma. Exposure to previous multiple chemotherapy and radiation treatment may lead to poor mobilization of PBSC. It is not known whether pre-treatment with bendamustine will adversely affect the process of PBSC mobilization and harvest. On the other hand, it is assumed that high dose alkylating agents like cyclophosphamide may actually help in breaking the bond between stem cells and the stromal cells in the marrow cavity and hence may lead to a better mobilization of PBSC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
non-Hodgkin's lymphoma, autologous stem cell transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rituximab
Arm Type
Active Comparator
Arm Title
bendamustine
Arm Type
Active Comparator
Arm Description
bendamustine, 90 mg/M2
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
Day 1 - rituximab, 375 mg/M2 IV (drug dosage is based on body weight)
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda
Intervention Description
Days 2 and 3 bendamustine, 90 mg/M2 IV over 30-60 minutes (drug dosage based on body weight)
Primary Outcome Measure Information:
Title
To assess the efficacy of G-CSF induced PBSC mobilization after two cycles of rituximab and Bendamustine (BR) as salvage therapy in patients with relapsed non-Hodgkins lymphoma
Time Frame
Quarterly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with relapsed or refractory C20+ non-Hodgkin's lymphoma (proven by biopsy, radiological findings or clinical exam) referred to BMT clinic of Kansas University Medical Center for consideration of autologous stem cell transplantation. No separate recruitment method or advertisement will be used to enroll patients. Age 18-70 years. Exclusion Criteria: Pregnancy and nursing mother Karnofsky performance status less than 50% 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 times 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siddhartha Ganguly, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Peripheral Blood Stem Cell (PBSC) Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine

We'll reach out to this number within 24 hrs