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

NCT01022021 | Completed Early Phase 1 DMC

• 1 other identifier: 11908
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

non-Hodgkin's lymphoma; autologous stem cell transplant

Outcome Measures

Primary Outcomes (1)

• 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

  Quarterly

Study Arms (2)

rituximab

ACTIVE COMPARATOR

Drug: Rituximab

bendamustine

ACTIVE COMPARATOR

bendamustine, 90 mg/M2

Drug: Bendamustine

Interventions

Rituximab DRUG

Day 1 - rituximab, 375 mg/M2 IV (drug dosage is based on body weight)

Also known as: Rituxan

rituximab

Bendamustine DRUG

Days 2 and 3 bendamustine, 90 mg/M2 IV over 30-60 minutes (drug dosage based on body weight)

Also known as: Treanda

bendamustine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Cephalon: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin

Interventions

Rituximab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Siddhartha Ganguly, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: December 1, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2015
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

US (1)