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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00948090

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

207

Starts

2010-01-01

Expected to finish

2013-06-01

Last updated by the study team

2014-07-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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