This protocol will develop an observational cohort of PLWH who have been or are being treated
      with CAR19 therapy outside of an AMC clinical trial. Following regulatory approval of this
      protocol, sites will be asked to capture information of participants, who carry a diagnosis
      of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017
      and August 31, 2021. Data captured will include data points are available as part of standard
      of care for participants undergoing CAR19 therapy. AMC investigators, as well as non-AMC
      investigators will identify eligible participants to the CIBMTR, who in turn will provide the
      AMC statistical center with de-identified data

Observational Study of People Living With HIV Treated With CD19-directed CAR T Cell

Leukemia

Leukemia, Lymphoblastic

Lymphoma, Large B-Cell, Diffuse

Follicular Lymphoma

Lymphoma, B-Cell

Lymphoma, Follicular

Lymphoma, Non-Hodgkin

HIV Infections

HIV Associated Lymphoma

HIV Disease; Lymphoma

Two landmark trials have led to the FDA approval of two different CD19 directed chimeric
      antigen receptor (CAR) T cell (CAR19) products in the United States for the treatment of
      relapsed or refractory (RR) large B-cell lymphoma after two or more lines of systemic
      therapy: tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta ®). In the ZUMA-1
      registration trial for axicabtagene ciloleucel (axi-cel), 42% of the 101 treated patients
      achieved a complete response (CR), and with a median follow up of 15 months, the projected
      1year progression free survival (PFS) was 70%. In a recent updated analysis, the CR rate was
      58% with about 40% of patients having durable remissions at 2 years of follow up. Similar
      results were seen in the JULIET registrational trial for tisagenlecleucel (tisa-cel) with an
      overall response rate (ORR) of 52%, and a CR rate of 40% in the 93 patients evaluable for
      response; with a median follow up of 14 months, the estimated 12-months relapse-free survival
      was 65% (79% among patients with a CR). Tisagenlecleucel is also approved for the treatment
      of acute B-lineage lymphoblastic leukemia in patients up to the age of 25 years.
      Unfortunately, in both trials patients with known HIV infection were excluded. Therefore, no
      safety or efficacy data for treatment with CAR19 in PLWH exists, and access for PLWH in the
      US to this potentially curative treatment has been limited.

      This has to be contrasted with the fact that malignancies, and specifically lymphomas, remain
      a major contributor to early mortality in PLWH. With a lifetime risk of cancer ranging
      between 24-40%, the leading cause of death in PLWH in economically developed countries is
      cancer, and the most common cancer in PLWH in the US remains Non-Hodgkin lymphoma (NHL).
      While early during the HIV epidemic, outcomes for PLWH and aggressive B-cell lymphomas were
      significantly worse compared to immunocompetent patients, this is no longer the case for the
      majority of PLWH, owing mainly to effective antiretroviral therapies leading to better
      tolerance of myelosuppressive chemotherapy and a consequent paradigm shift in aggressive
      therapies for HIV-associated lymphoma. It has been repeatedly demonstrated that PLWH have
      been able to safely tolerate aggressive high-dose chemotherapy, as well as autologous and
      even allogeneic hematopoietic cell transplant.

Observational Cohort Study of People Living With HIV Treated With CD19-directed CAR T Cell Therapy for B-cell Lymphoid Malignancies

Toxicities related to CAR19 therapy will be reported by Common Terminology for Adverse Events (CTCAE) criteria, as well as American Society for Transplantation and Cellular Therapy (ASTCT) criteria (for cytokine release syndrome)

CD4 count on day of leukapheresis, 3 months post CAR19 therapy, 6 months post CAR19 therapy, and 12-months post therapy will be measured

Absolute lymphocyte count on day of leukapheresis, 3 months post CAR19 therapy, 6 months post CAR19 therapy, and 12-months post therapy will be measured

HIV viral load on day of leukapheresis, 3 months post CAR19 therapy, 6 months post CAR19 therapy, and 12-months post therapy will be measured

Defined as complete remission plus partial remission

Defined as complete disappearance of all disease

Clinical information on participants, who carry a diagnosis of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017 and August 31, 2021 will be captured

Observational Study of People Living With HIV Treated With CD19-directed CAR T Cell

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status