Trials / Active Not Recruiting
Active Not RecruitingNCT01961063
Gene Therapy After Frontline Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma
Safety and Feasibility of Gene Transfer After Frontline Chemotherapy for Non-Hodgkin Lymphoma in AIDS Patients Using Peripheral Blood Stem/Progenitor Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (estimated)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies gene therapy after frontline chemotherapy in treating patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma (NHL). Placing genes for anti-human immunodeficiency virus (HIV) ribonucleic acid (RNA) into stem/progenitor cells may make the body build an immune response to AIDS. Giving the chemotherapy drug busulfan before gene therapy can help gene-modified cells engraft and work better.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the safety and feasibility of recombinant (r)HIV7-short hairpin RNA targeted to the HIV-1 tat/rev (shI)-trans-active response element (TAR)-chemokine cysteine-cysteine receptor 5 ribozyme (CCR5RZ)-treated hematopoietic stem progenitor cells (HSPC) (lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells) infusion in AIDS patients completing treatment for NHL and non-myeloablative conditioning with busulfan. II. To demonstrate the engraftment of gene-modified progeny cells following such treatment. III. To determine if selection of these gene-modified progeny cells occurs during analytical treatment interruption (ATI) of combination anti-retroviral therapy (cART). SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of busulfan in patients with AIDS-related lymphoma (ARL). II. To determine the effects of HIV-1 infection on the presence of gene-marked peripheral blood mononuclear cells (PBMC) as measured by woodchuck post-transcriptional regulatory element (WPRE) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) performed before, during, and after ATI. OUTLINE: Patients receive busulfan intravenously (IV) over 3 hours on day -2 followed by lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells IV on day 0. After completion of study treatment, patients are followed up at 1, 7, 14, and 21 days and 1, 2, 3, 6, 9, 12, 18, and 24 months and then annually for 3 years.
Conditions
- AIDS-related Non-Hodgkin Lymphoma
- AIDS-related Plasmablastic Lymphoma
- AIDS-related Primary Effusion Lymphoma
- HIV Infection
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | busulfan | Given IV |
| BIOLOGICAL | lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells | Given IV |
| OTHER | pharmacological study | Correlative studies |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2015-12-31
- Primary completion
- 2026-08-05
- Completion
- 2026-08-05
- First posted
- 2013-10-11
- Last updated
- 2025-11-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01961063. Inclusion in this directory is not an endorsement.