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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Agnes Elekes, MD

Investigator Role:

Study Director

Investigator Affiliation:

Otsuka Pharmaceutical Development and commercialization

Authority:

United States: Food and Drug Administration

Study ID:

273-08-201

NCT ID:

NCT00948090

Start Date:

January 2010

Completion Date:

July 2013

Related Keywords:

  • Lymphoma
  • Hodgkin Lymphoma
  • Non-Hodgkin's Lymphoma
  • Bone marrow transplant
  • stem cell transplant
  • busulfan
  • cyclophosphamide
  • etoposide
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Ann Arbor, Michigan  48109-0624
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Medical University of South Carolina Charleston, South Carolina  29425-0721
Huntsman Cancer Institute Salt Lake City, Utah  84112
Cedars-Sinai Medical Center Los Angeles, California  90048
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Scripps Clinic La Jolla, California  92037
Sutter Cancer Center Sacramento, California  95816
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Florida Hospital Cancer Institute Orlando, Florida  32804
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Baylor University Medical Center Dallas, Texas  75246
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Oregon Health & Science University Portland, Oregon  97201
Duke University Medical Center Durham, North Carolina  27710
Emory University Atlanta, Georgia  30322
The Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
University of California, Davis Medical Center Sacramento, California  
Virginia Commonwealth University Richmond, Virginia  
The University of Chicago Chicago, Illinois  60637
University of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599
Sarah Cannon Research Institute Nashville, Tennessee  37203
Weill Cornell Medical College New York, New York  10021
South Texas Veterans Health Care System San Antonio, Texas  78229
University of California San Francisco Medical Center San Francisco, California  94143
West Virginia University Hospital Morgantown, West Virginia  26506-9162
Alta Bates Summit Medical Center Berkeley, California  94704
Loyola University Chicago Maywood, Illinois  60153
Montefiore-Einstein Cancer Center Bronx, New York  10461
University of Alabama in Birmingham Birmingham, Alabama  35294
UCSD Medical Center BMT Program La Jolla, California  92093
Bone Marrow and Stem Cell Transplant Program Indianapolis, Indiana  46202
LSU Health Sciences Center at Shreveport/Feist Weiller Cancer Center Shreveport, Louisiana  71103
University of Maryland Medical Center - Marlene & Stewart Greenebaum Cancer Center Baltimore, Maryland  21201
Texas Transplant Physician Group, PLLC San Antonio, Texas  78229