PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
A Multi-center, Phase 2, Single-Arm, Open-Label Exploratory Study of Individually- Optimized Conditioning Using Pharmacokinetics [PK]-Directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in Subjects With Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma
1 other identifier
interventional
207
2 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Jan 2010
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2009
CompletedFirst Posted
Study publicly available on registry
July 29, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
July 31, 2014
CompletedJuly 31, 2014
July 1, 2014
3.3 years
July 28, 2009
May 21, 2014
July 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Progression Events in 2 Years.
The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.
2 years
Secondary Outcomes (3)
Number of Death Events in 2 Years.
2 years
Number of Transplant-related Death Events Until Day 100.
Day 100
Overall Response Rate
Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination)
Study Arms (1)
IV Busulfan
EXPERIMENTALPk-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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
University of Alabama in Birmingham
Birmingham, Alabama, 35294, United States
Arizona Cancer Center
Tucson, Arizona, 85719, United States
Alta Bates Summit Medical Center
Berkeley, California, 94704, United States
Scripps Clinic
La Jolla, California, 92037, United States
UCSD Medical Center BMT Program
La Jolla, California, 92093, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Bone Marrow and Stem Cell Transplant Program
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Westwood, Kansas, 66205, United States
LSU Health Sciences Center at Shreveport/Feist Weiller Cancer Center
Shreveport, Louisiana, 71103, United States
University of Maryland Medical Center - Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Montefiore-Einstein Cancer Center
The Bronx, New York, 10467, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
South Texas Veterans Health Care System
San Antonio, Texas, 78229, United States
Texas Transplant Physician Group, PLLC
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Queen Elizabeth II Health Sciences Centre - VG Site
Halifax, Nova Scotia, B3H 2Y9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Royal Victoria Hospital MUHC
Montreal, Quebec, H3A 1A1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Affairs
- Organization
- Otsuka Pharmaceutical Development and Commercialization, Inc.
Study Officials
- STUDY DIRECTOR
Agnes Elekes, MD
Otsuka Pharmaceutical Development and commercialization
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2009
First Posted
July 29, 2009
Study Start
January 1, 2010
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
July 31, 2014
Results First Posted
July 31, 2014
Record last verified: 2014-07