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Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2009 by Office of Rare Diseases (ORD)
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00010348
First received: February 2, 2001
Last updated: May 13, 2009
Last verified: May 2009

February 2, 2001
May 13, 2009
November 2000
December 2010   (final data collection date for primary outcome measure)
Mortality due to infection, donor chimerism [ Time Frame: Days 14, 28, 56, 80, 180, and 360 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00010348 on ClinicalTrials.gov Archive Site
CD4, viral load [ Time Frame: Days 14, 28, 56, 80, 180, and 360 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil

OBJECTIVES:

I. Determine the safety of total body irradiation and post-transplant cyclosporine and mycophenolate mofetil in high-risk patients with human immunodeficiency virus-1.

II. Determine whether this regimen results in stable mixed donor lymphocyte chimerism (5-95% donor CD3) in this patient population.

III. Determine the kinetics of immune reconstruction following this treatment regimen in this patient population.

IV. Determine the effect of this treatment regimen on viral load in this patient population.

PROTOCOL OUTLINE:

Patients receive oral or IV cyclosporine 2-3 times daily on Days -1 to 50. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0 (assuming donor is available). Beginning within 6 hours of transplantation, patients receive oral mycophenolate mofetil every 12 hours until Day 27.

Patients with an unstable level of chimerism may receive 1-2 donor lymphocyte infusions.

Patients are followed at Days 14, 28, 56, 80, 180, and 360.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Cyclosporine
    Oral or IV cyclosporine 2 to 3 times daily on Days -1 to 50
  • Drug: Mycophenolate mofetil
    Beginning within 6 hours of transplantation, oral mycophenolate mofetil every 12 hours until Day 27.
  • Procedure: Total body irradiation and stem cell or bone marrow transplantation
    Assuming donor is available, total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0.
Experimental: 1
Participants will receive a stem cell transplantation along with a non-marrow ablative conditioning regimen containing total bdoy irradiation combined with post-transplant immunosuppression with cyclosporine and mycophenolate mofetil
Interventions:
  • Drug: Cyclosporine
  • Drug: Mycophenolate mofetil
  • Procedure: Total body irradiation and stem cell or bone marrow transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2015
December 2010   (final data collection date for primary outcome measure)

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Diagnosis of human immunodeficiency virus-1 not responsive to highly active antiretroviral therapy (HAART); treated with HAART for at least the past 6 months; viral load less than 50 copies/mL plasma; CD4 count less than 100/mm3
  • Lymphoma or other HIV-associated malignancy allowed with the following criteria: malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence of continued tumor growth; viral load has decreased by at least 1.5 logs OR to less than 5,000 copies/mL plasma while on HAART; CD4 count is allowed to be greater than 100/mm3
  • HLA genotypically identical donor available (under 75 years of age)

--Prior/Concurrent Therapy--

  • No concurrent growth factors during mycophenolate mofetil administration; concurrent continuation of anti-retroviral therapy required

--Patient Characteristics--

  • Life expectancy: At least 30 days
  • Other: No positive serology for Toxoplasma gondii; no other disease or organ dysfunction that would preclude survival; not pregnant or nursing; fertile patients must use effective contraception during and for 1 year after study
Both
up to 64 Years
No
United States
 
NCT00010348
199/15576, FHCRC-1410.00
Yes
Ann Woolfrey / Associate in Clinical Research, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Not Provided
Study Chair: Ann Woolfrey Fred Hutchinson Cancer Research Center
Office of Rare Diseases (ORD)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP