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NCT02846376: CPIT-002

Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant

Terminated Phase 1 Last updated 18 November 2024
What this trial tests

Phase 1 trial testing Nivolumab in Acute Myeloid Leukemia and Myelodysplastic Syndrome in 8 participants. Terminated before completion.

Timeline
8 March 2019
Primary endpoint
21 December 2023
21 December 2023

Quick facts

Lead sponsorHackensack Meridian Health
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment8
Start date8 March 2019
Primary completion21 December 2023
Estimated completion21 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hackensack Meridian Health — full company profile →

Who can join

Adults 18 to 70, any sex, with Acute Myeloid Leukemia and Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or the combination of nivolumab with ipilimumab given after bone marrow transplant for patients with acute myelogenous leukemia and myelodysplastic syndrome.

Publications & conference data

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

  1. Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
    Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9
  2. T-cell-based immunotherapy of acute myeloid leukemia: current concepts and future developments.
    Daver N, Alotaibi AS, Bücklein V, Subklewe M. · · 2021 · cited 178× · PMID 33953290 · DOI 10.1038/s41375-021-01253-x
  3. Recent advances in targeted therapies in acute myeloid leukemia.
    Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
  4. Dysregulated haematopoietic stem cell behaviour in myeloid leukaemogenesis.
    Yamashita M, Dellorusso PV, Olson OC, Passegué E. · · 2020 · cited 128× · PMID 32415283 · DOI 10.1038/s41568-020-0260-3
  5. Precision therapy for acute myeloid leukemia.
    Yang X, Wang J. · · 2018 · cited 109× · PMID 29301553 · DOI 10.1186/s13045-017-0543-7
  6. Targeting the Immune Microenvironment in Acute Myeloid Leukemia: A Focus on T Cell Immunity.
    Lamble AJ, Lind EF. · · 2018 · cited 95× · PMID 29951373 · DOI 10.3389/fonc.2018.00213
  7. Checkpoint inhibitors in hematological malignancies.
    Ok CY, Young KH. · · 2017 · cited 93× · PMID 28482851 · DOI 10.1186/s13045-017-0474-3
  8. Advances in targeted therapy for acute myeloid leukaemia.
    Kayser S, Levis MJ. · · 2018 · cited 88× · PMID 29193012 · DOI 10.1111/bjh.15032

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