NCT01961063 is a Phase 1 clinical trial of busulfan in AIDS-related Non-Hodgkin Lymphoma, sponsored by City of Hope Medical Center.

Who is sponsoring NCT01961063?

NCT01961063 is sponsored by City of Hope Medical Center.

What drugs are being tested in NCT01961063?

Interventions in NCT01961063: busulfan, lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells, pharmacological study, laboratory biomarker analysis.

What condition does NCT01961063 study?

NCT01961063 studies AIDS-related Non-Hodgkin Lymphoma, AIDS-related Plasmablastic Lymphoma, AIDS-related Primary Effusion Lymphoma, HIV Infection.

Is NCT01961063 still recruiting?

NCT01961063 is currently active, enrolled. Last updated 26 November 2025.

Last reviewed 2025-11-26 · How we verify

NCT01961063

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Gene Therapy After Frontline Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma

Active, enrolled Phase 1 Last updated 26 November 2025

What this trial tests

Phase 1 trial testing busulfan in AIDS-related Non-Hodgkin Lymphoma in 3 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 December 2015

Primary endpoint
5 August 2026

5 August 2026

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	31 December 2015
Primary completion	5 August 2026
Estimated completion	5 August 2026
Sites	1 location across United States

Drugs / interventions tested

busulfan — full drug profile →
lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells — full drug profile →
pharmacological study — full drug profile →
laboratory biomarker analysis — full drug profile →

Conditions studied

AIDS-related Non-Hodgkin Lymphoma — all drugs for AIDS-related Non-Hodgkin Lymphoma →
AIDS-related Plasmablastic Lymphoma — all drugs for AIDS-related Plasmablastic Lymphoma →
AIDS-related Primary Effusion Lymphoma — all drugs for AIDS-related Primary Effusion Lymphoma →
HIV Infection — all drugs for HIV Infection →

Sponsor

City of Hope Medical Center

Who can join

Adults 18 to 65, any sex, with AIDS-related Non-Hodgkin Lymphoma or AIDS-related Plasmablastic Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Gene Therapy Leaves a Vicious Cycle.
Goswami R, Subramanian G, Silayeva L, Newkirk I, et al · · 2019 · cited 221× · PMID 31069169 · DOI 10.3389/fonc.2019.00297
HIV-specific Immunity Derived From Chimeric Antigen Receptor-engineered Stem Cells.
Zhen A, Kamata M, Rezek V, Rick J, et al · · 2015 · cited 120× · PMID 26050990 · DOI 10.1038/mt.2015.102
Cell therapies in the clinic.
Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
RNA Interference as a Prospective Tool for the Control of Human Viral Infections.
Levanova A, Poranen MM. · · 2018 · cited 73× · PMID 30254624 · DOI 10.3389/fmicb.2018.02151
Immunological barriers to haematopoietic stem cell gene therapy.
Charlesworth CT, Hsu I, Wilkinson AC, Nakauchi H. · · 2022 · cited 47× · PMID 35301483 · DOI 10.1038/s41577-022-00698-0
Viral oncogenesis in cancer: from mechanisms to therapeutics.
Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9
Recent advances in RNAi-based strategies for therapy and prevention of HIV-1/AIDS.
Swamy MN, Wu H, Shankar P. · · 2016 · cited 34× · PMID 27013255 · DOI 10.1016/j.addr.2016.03.005
RNA Interference Therapies for an HIV-1 Functional Cure.
Scarborough RJ, Gatignol A. · · 2017 · cited 29× · PMID 29280961 · DOI 10.3390/v10010008

Verify or expand the search:

Other trials of busulfan

Trials testing the same drug.

NCT07441967 — The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Bu · Phase 2 · not yet recruiting
NCT04690192 — CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma · Phase 1, PHASE2 · completed
NCT02999984 — Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID · Phase 1, PHASE2 · completed
NCT02248597 — Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases · Phase 2 · completed
NCT02129582 — Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Pat · Phase 1 · completed

Other City of Hope Medical Center trials

Trials by the same sponsor.

NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01961063 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 26 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01961063.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing