This is a Phase II multi-center trial single arm trial of autologous transplantation (ASCT) followed by administration of HST-NEETs for treatment of HIV associated lymphoma
Eligible participants will have 100-120 mL of peripheral blood or 80-100 mL of MNCs via apheresis collected and shipped to Children's National Hospital at ambient temperature. The sample will be used to manufacture the HST-NEET product. The autologous peripheral blood stem cell graft suitable for rescue following conditioning will be obtained either before or after the collection of blood to generate HST-NEETs. Pre-transplant conditioning will consist of BEAM; BCNU 300 mg/m\^2 on Day -6, Etoposide 100 mg/m\^2 BID and Ara-C 100 mg/m2 BID on Days -5, -4, -3 and -2 and Melphalan 140 mg/m2 on Day -1. ASCT on Day 0. If the mobilized graft contains greater than 5.0 x 106 CD34+ cells per kg, any additional cells should be cryopreserved as a "back-up" graft in the event of graft failure related to the HST-NEETs. Participants will receive one dose (2 x 107 cells/m\^2 ) of HST-NEETs between Days +3 to +7 based on the clinical condition of the participant. If this window is missed, the HST-NEETs may be administered up to Day +30 post-ASCT. Participants will be followed for at least one year after ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
HST-NEETs are manufactured from an autologous peripheral blood or MNCs via apheresis collection and will be administered as a single intravenous (IV) infusion of 2x10\^7/m\^2 cells between 3 Days and 7 Days post-ASCT.
Day 0 is the day of bone marrow transplantation.
City of Hope National Medical Center
Duarte, California, United States
Georgetown
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
To determine 1.) the proportion of participants who can be treated with (HST-NEETs) within 1 week of ASCT in a cooperative multi-institutional setting and 2.) the efficacy of HSTNEETs in reducing the HIV intact proviral
Feasibility is defined as a participant receiving HST-NEETs within 1 week post-ASCT; Efficacy will be measured by the reduction in intact proviral reservoir.
Time frame: 6 Months
Progression-free survival
Participants are considered a failure for this endpoint if they die or if they relapse/progress or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (greater than 3cm)
Time frame: 6 Months and 1 Year
The incidence and severity of acute infusion related toxicities
Acute infusion related toxicities are defined as toxicities related to the infusion of HST-NEETs that occur within 24 hours of the infusion.
Time frame: 1 Year
Impact of therapy on the HIV intact proviral reservoir
Impact on intact proviral reservoir will be assessed using the IPDA at 4-8 weeks prior to transplant and 12 months following ASCT
Time frame: 1 Year
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Northside
Atlanta, Georgia, United States
University of Illinois
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering (MSKCC)
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
...and 1 more locations