Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant (NCT02797470)

🧪 Interventions in This Study

• Carmustine (DRUG)
• Cytarabine (DRUG)
• Etoposide (DRUG)
• Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells (BIOLOGICAL)
• Melphalan (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Inclusion criteria associated with type and status of lymphoma, one of the following must be applicable:
2. Biopsy-proven intermediate or high-grade non-Hodgkin's lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment in the screening segment): \- In partial remission, \- Relapsed after initial complete remission, \- Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease), \- In complete remission with high-risk features as specified by the International Prognostic Index.
3. Biopsy-proven advanced stage follicular lymphoma, that have failed at least two lines of therapy multi-agent chemotherapy, but responds to salvage therapy i.e.,chemosensitive disease) (timeline 8 months prior to enrollment in the screening segment).
4. Biopsy-proven advanced stage Mantle cell lymphoma with Ki-67 \> 10% in first complete remission (timeline 8 months prior to enrollment in the screening segment).
5. Biopsy-proven Hodgkin's lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment). \- In first, or greater relapse after initial complete remission, \- In partial remission, \- Failed induction therapy, but responds to salvage therapy (i.e., chemosensitive disease).
6. Biopsy-proven Burkitt's lymphoma, meeting one of the following criteria (timeline 8 months prior to enrollment): \- In second complete remission after relapse following initial complete remission, \- Failed induction therapy, but responds (very good partial remission, complete remission, or near complete remission) to salvage therapy (i.e., chemosensitive disease).
7. Biopsy proven plasmablastic lymphomas, or peripheral T cell lymphoma (with the exception of ALK+ type in first or second complete remission) \*NOTE: Patients meeting the following criteria are exempt from the 8-month timeline and do not require additional biopsy:
8. Patients who have never achieved a complete remission on the last biopsy-proven site of disease and went on to the next therapy then achieved a complete remission.
9. Patients who relapsed quickly (within 3 months of their last chemotherapy) and now have achieved a complete remission with salvage therapy.
10. Inclusion criteria associated with HIV-1 status
11. HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or ELISA, test kit, and confirmed by Western blot or other approved test). Alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection.
12. Must be on a multi-drug anti-HIV regimen (excluding zidovudine \[AZT, ZDV, Retrovir®, or agents containing zidovudine (e.g., Combivir® and Trizivir®)\], and efavirenz \[Sustiva®, or agents containing efavirenz (e.g., Atripla®)\]). Participants on zidovudine \[AZT, ZDV, Retrovir®; including Combivir® and Trizivir®\] and efavirenz \[Sustiva®; including Atripla®\] must switch to an alternative regimen without anticipated drug-drug interactions or myelosuppressive properties based on known viral resistance patterns and/or ART history, such as raltegravir and Truvada (emtricitabine and tenofovir) at least two weeks prior to the transplant. o Participant taking ARTs must satisfy one of the following:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

• UC San Diego Moores Cancer Center — La Jolla, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• UCSF Medical Center-Parnassus — San Francisco, California
• Memorial Sloan Kettering Cancer Center — New York, New York

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in HIV Infection

• Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study — La Jolla, California
• Baricitinib Curative Repression of HIV-1 — Atlanta, Georgia
• Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up — Mexico City, Mexico City
• HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients — Dallas, Texas
• The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection — New York, New York

Explore by condition: All HIV Infection clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.