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Gene Therapy and Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Started2015-11-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 8, 2026 → Aug 9, 2027
See other at-risk trials from City of Hope Medical Center

Amendment history

2026-10-02
Primary completion pushed: 2026-09-08 → 2027-08-09
Completion pushed: 2026-09-08 → 2027-08-09
2025-11-06
Study Status v26
Primary completion date2025-10-02→2026-09-08
Completion date2025-10-02→2026-09-08
2025-02-04
Study Status v25
Primary completion date2024-12-30→2025-10-02
Completion date2024-12-31→2025-10-02
2024-01-29
Study Status v24
Primary completion date2023-12-30→2024-12-30
Completion date2023-12-31→2024-12-31
2023-08-03
Study Status v23
Primary completion date2023-06-30→2023-12-30
Show 22 earlier versions
2022-07-31
Study Status v22
Primary completion date2022-06-30→2023-06-30
Completion date2022-12-31→2023-12-31
Start date2015-08-03→2015-11-20
2022-03-28
Study Status v21
Primary completion date2021-12-31→2022-06-30
Completion date2021-12-31→2022-12-31
2021-06-12
Study Status v20
Primary completion date2022-06→2021-12-31
Completion date2022-06→2021-12-31
2020-06-04
Study Status v19
Re-verified, no change to tracked fields
2019-04-29
Study Status v18
Primary completion date2019-02→2022-06
Completion date2019-02→2022-06
2018-11-16
Study Status v17
Re-verified, no change to tracked fields
2018-05-18
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2018-04-05
Study Status v15
Primary completion date2018-03→2019-02
Completion date2018-03→2019-02
2018-02-16
Study Status, Study Design v14
PhaseNot applicable→Phase 1
2018-01-11
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
2017-08-10
Study Status v12
Re-verified, no change to tracked fields
2017-05-01
Study Status, Oversight, Outcome Measures, Eligibility v11
Eligibility criteria+27 characters
[...] ubjects must have collected at least 5 x 10^6 CD34+ cells/kg by apheresis after Cycle 4 Exclusion Criteria: Any AIDS-related opportunistic infectio [...]
Primary endpoints4 entries, revised
Presence of transgene in peripheral blood by quantitativedigital droplet PCR (TaqMAn analysis)
2017-02-23
Active, Not Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v10
Trial statusActive, Not Recruiting→Recruiting
Completion datenot stated→2018-03
Start date2015-08→2015-08-03
Study sitesdetails revised at 1 of 1 site
2016-11-17
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2016-09-29
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v8
Eligibility criteria+403 characters
Inclusion Criteria: HIV seropositive at or before the time of lymphoma diagnosis; all HIV positive patients are eligible regardless of HIV viral load or antiviral therapy (ART) status; all patients on study will receive ART as per standard guidelines Eastern Cooperative Oncology Group (ECOG) performance statu [...] conditions that would hinder study compliance and follow-up SerumPretreatment serum glutamic oxaloacetic transaminase (SGOT), serum glutamate p [...] e (SGPT) =< 2.5 x institutional upper limit of normal (ULN) SerumPretreatment serum bilirubin =< 2.5 x ULN Total or total bilirubin < 4.5 mg/dl wit [...] [...]
Study description-16 characters
[...] AR-CCR5RZ-transduced hematopoietic stem/progenitor cells IV over 15 minutes on day 0 (48 hours after the final combination chemotherapy [...]
2016-05-11
Study Status v7
Re-verified, no change to tracked fields
2015-11-16
Study Status, Study Description, Arms and Interventions, Outcome Measures v6
Primary endpoints4 entries, revised
[...] n Terminology Criteria for Adverse Events (CTCAE) version 4.003 Incidence of adverse events related to lentivirus vector rH [...] enitor cells infusion, graded using the NCI CTCAE version 4.003
Study description+34 characters
[...] then receive filgrastim subcutaneously (SC) once daily (QD) beginning on day 6 and continuing until absolute neutrophil count recovers. Treatment repeats [...]
2015-09-10
Study Status v5
Primary completion date2031-08→2018-03
2015-08-31
Study Status, Study Design, Eligibility v4
Enrollment target5→10
Eligibility criteria+93 characters
[...] RITERIA FOR HSPC TRANSPLANTATION Patients must demonstrate >= 75% disease reduction on computed tomography (CT) scan (confirmed by PET scan) after the third cycle of R-EPOCH relative to baseline, with no evidence of disease progression after the fifth cycle Subjects must complete the filgrastim (G-CSF)/plerixafor mo [...]
2015-08-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2031-06→2031-08
Start date2015-12→2015-08
Study sitesdetails revised at 1 of 1 site
2015-07-22
Study Status v2
Start date2015-04→2015-12
2015-02-11
Study Status v1
Start date2015-01→2015-04
2015-01-09
Original filing
This pilot clinical trial studies gene therapy following combination chemotherapy in treating patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma. Placing genes that have been shown in the laboratory to inhibit the growth and spread of the immunodeficiency virus (HIV) into the patient's peripheral blood stem cells may improve the body's ability to fight HIV. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving gene therapy after combination chemotherapy may improve the body's ability to fight HIV and AIDS-related non-Hodgkin lymphoma.
Trial Details
NCT Number NCT02337985
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions AIDS-Related Burkitt Lymphoma, AIDS-Related Diffuse Large B-cell Lymphoma, AIDS-Related Plasmablastic Lymphoma, AIDS-Related Primary Effusion Lymphoma, HIV Infection, AIDS Related Non-Hodgkin Lymphoma
Enrollment 10 participants
Start Date 2015-11-20
Primary Completion 2027-08-09 (estimated)
Study Completion 2027-08-09 (estimated)
Updated on ClinicalTrials.gov 2026-10-01