Clinical trial · Interventional
Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| HIV Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Leukapheresis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (HIV-specific immune reconstitution after HCT)
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Procedure: Leukapheresis
Primary outcomes (2)
- measure
- Quantification of donor-derived HIV-1-specific immune responses following HCT
- timeFrame
- Up to 1 year
- description
- HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively.
- measure
- Quantification of latently infected CD4+ cells in HIV+ patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available