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 - Tabular View

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

May 13, 2009

Start Date ^ICMJE

November 2000

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00010348 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Cyclosporine
Drug: Mycophenolate mofetil
Procedure: Total body irradiation and stem cell or bone marrow transplantation

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00010348

Responsible Party

Ann Woolfrey / Associate in Clinical Research, Fred Hutchinson Cancer Research Center

Study ID Numbers ^ICMJE

199/15576, FHCRC-1410.00

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Ann Woolfrey

Fred Hutchinson Cancer Research Center

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

May 2009

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