PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients

NCT ID: NCT00948090

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-06-30

Brief Summary

This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.

Detailed Description

Evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with NHL and HL receiving an IV busulfan-based conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning regimen (and its variants) obtained from registry data in the Center for International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be completed.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV Busulfan

Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant

Group Type: EXPERIMENTAL

IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)

Intervention Type: DRUG

Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.

Interventions

IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)

Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects with NHL to be included:

• Any subject with NHL that had relapsed or progressed following initial therapy with an anthracycline-based chemotherapy regimen and has achieved a subsequent partial remission (PR) or a complete remission (CR) following a salvage chemotherapy regimen.
• Any subject with NHL that was initially refractory to an anthracycline-based chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
• Any subject with an initial International Prognostic Index (IPI) score 4-5 who achieved a PR or any CR following an anthracycline-based chemotherapy regimen except subjects with Mantle cell, T cell and Natural Killer (NK) cell pathologies.
• Subjects with Mantle cell, T cell and NK cell lymphoma may be enrolled if they have PR or CR after initial therapy.
• Any subject that has relapsed or progressed following previous autologous HSCT.

Subjects with HL to be included:

• Any subject with HL that had relapsed or progressed following initial therapy with an multi-drug chemotherapy regimen and has achieved a subsequent PR or a CR following a salvage chemotherapy regimen.
• Any subject with HL that is initially refractory to a multi-drug chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
• Any subject that has relapsed or progressed following previous autologous HSCT.

Exclusion Criteria

• Any subject with chemoresistant disease by demonstration of less than PR to most recent chemotherapy, and any subject with prior treatment history of autologous HSCT or high-dose chemotherapy with stem cell rescue for any medical reason will be excluded.

Excluded will also be subjects with existing or active central nervous system lymphoma or human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled infections.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for International Blood and Marrow Transplant Research

NETWORK

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnes Elekes, MD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development and commercialization

Locations

University of Alabama in Birmingham

Birmingham, Alabama, United States

Arizona Cancer Center

Tucson, Arizona, United States

Alta Bates Summit Medical Center

Berkeley, California, United States

Scripps Clinic

La Jolla, California, United States

UCSD Medical Center BMT Program

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Sutter Cancer Center

Sacramento, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

The University of Chicago

Chicago, Illinois, United States

Loyola University Chicago

Maywood, Illinois, United States

Bone Marrow and Stem Cell Transplant Program

Indianapolis, Indiana, United States

University of Kansas Medical Center

Westwood, Kansas, United States

LSU Health Sciences Center at Shreveport/Feist Weiller Cancer Center

Shreveport, Louisiana, United States

University of Maryland Medical Center - Marlene & Stewart Greenebaum Cancer Center

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Weill Cornell Medical College

New York, New York, United States

Montefiore-Einstein Cancer Center

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

South Texas Veterans Health Care System

San Antonio, Texas, United States

Texas Transplant Physician Group, PLLC

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Queen Elizabeth II Health Sciences Centre - VG Site

Halifax, Nova Scotia, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Royal Victoria Hospital MUHC

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Countries

United States; Canada

Other Identifiers

273-08-201

Identifier Type: -

Identifier Source: org_study_id