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 - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00010348

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Cyclosporine Drug: Mycophenolate mofetil Procedure: Total body irradiation and stem cell or bone marrow transplantation	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Bone Marrow Transplantation

Drug Information available for: Cyclosporine Cyclosporin Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Primary Outcome Measures:

Mortality due to infection, donor chimerism [ Time Frame: Days 14, 28, 56, 80, 180, and 360 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

CD4, viral load [ Time Frame: Days 14, 28, 56, 80, 180, and 360 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	November 2000
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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	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.

Arms

Assigned Interventions

1: Experimental

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

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010348

Locations

United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 98109
Contact: Ann Woolfrey 206-667-4453

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

Investigators

Study Chair:

Ann Woolfrey

Fred Hutchinson Cancer Research Center

More Information

No publications provided

Responsible Party:	Fred Hutchinson Cancer Research Center ( Ann Woolfrey / Associate in Clinical Research )
Study ID Numbers:	199/15576, FHCRC-1410.00
Study First Received:	February 2, 2001
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00010348 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

human immunodeficiency virus infection
immunologic disorders and infectious disorders
rare disease
viral infection

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Antibiotics, Antineoplastic
Infection
Cyclosporins
Therapeutic Uses
Antifungal Agents

Mycophenolate mofetil
Dermatologic Agents
Retroviridae Infections
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 09, 2009