Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection
Conditions
Brief summary
This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.
Detailed description
PRIMARY OBJECTIVES: I. Examine the development of donor-derived HIV-1-specific immune response following hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+ patients. II. Examine the affect of HCT on the pool of latently infected cluster of differentiation (CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy. OUTLINE: Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.
Interventions
OTHERLaboratory Biomarker Analysis
Correlative studies
PROCEDURELeukapheresis
Undergo leukapheresis
Sponsors
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* HIV positive * Treatment with highly active antiretroviral therapy (HAART) for at least 1 month * Viral load has decreased by \>= 1.5 logs or viral load \< 5000 copies/ml plasma on HAART therapy * Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated * Approval for allogenic regimen given at Patient Care Conference * DONOR: Autologous or allogeneic gene modified cells allowed
Exclusion criteria
* A medical history of noncompliance with HAART or medical therapy * Inability to provide informed consent * DONOR: Allogeneic donors must not have HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of donor-derived HIV-1-specific immune responses following HCT | Up to 1 year | HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively. |
| Quantification of latently infected CD4+ cells in HIV+ patients | Up to 7 years | The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million. |
Countries
United States
Outcome results
None listed