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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 CenterTucson, Arizona  85724
University of MichiganAnn Arbor, Michigan  48109-0624
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Scripps ClinicLa Jolla, California  92037
Sutter Cancer CenterSacramento, California  95816
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Florida Hospital Cancer InstituteOrlando, Florida  32804
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Baylor University Medical CenterDallas, Texas  75246
Rocky Mountain Cancer CentersThornton, Colorado  80260
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
Emory UniversityAtlanta, Georgia  30322
The Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
University of California, Davis Medical CenterSacramento, California  
Virginia Commonwealth UniversityRichmond, Virginia  
The University of ChicagoChicago, Illinois  60637
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Sarah Cannon Research InstituteNashville, Tennessee  37203
Weill Cornell Medical CollegeNew York, New York  10021
South Texas Veterans Health Care SystemSan Antonio, Texas  78229
University of California San Francisco Medical CenterSan Francisco, California  94143
West Virginia University HospitalMorgantown, West Virginia  26506-9162
Alta Bates Summit Medical CenterBerkeley, California  94704
Loyola University ChicagoMaywood, Illinois  60153
Montefiore-Einstein Cancer CenterBronx, New York  10461
University of Alabama in BirminghamBirmingham, Alabama  35294
UCSD Medical Center BMT ProgramLa Jolla, California  92093
Bone Marrow and Stem Cell Transplant ProgramIndianapolis, Indiana  46202
LSU Health Sciences Center at Shreveport/Feist Weiller Cancer CenterShreveport, Louisiana  71103
University of Maryland Medical Center - Marlene & Stewart Greenebaum Cancer CenterBaltimore, Maryland  21201
Texas Transplant Physician Group, PLLCSan Antonio, Texas  78229