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NCT05222984

Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax

Active, enrolled Phase 1 Last updated 30 May 2025
What this trial tests

Phase 1 trial testing Decitabine in Recurrent Acute Myeloid Leukemia in 17 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
29 July 2022
Primary endpoint
2 April 2026
2 April 2026

Quick facts

Lead sponsorCity of Hope Medical Center
PhasePhase 1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment17
Start date29 July 2022
Primary completion2 April 2026
Estimated completion2 April 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

City of Hope Medical Center

Who can join

16 and older, any sex, with Recurrent Acute Myeloid Leukemia or Refractory Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib trial is to find the side effect and best dose of navitoclax when given together with venetoclax and decitabine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory) after previous treatment with venetoclax. Chemotherapy drugs, such as navitoclax, venetoclax, and decitabine, 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.

Publications & conference data

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

  1. Targeting senescence as an anticancer therapy.
    Bousset L, Gil J. · · 2022 · cited 70× · PMID 36065138 · DOI 10.1002/1878-0261.13312
  2. Programmed cell death: molecular mechanisms, biological functions, diseases, and therapeutic targets.
    Qian S, Long Y, Tan G, Li X, et al · · 2024 · cited 24× · PMID 39619229 · DOI 10.1002/mco2.70024
  3. Venetoclax: A New Partner in the Novel Treatment Era for Acute Myeloid Leukemia and Myelodysplastic Syndrome.
    El-Cheikh J, Bidaoui G, Saleh M, Moukalled N, et al · · 2023 · cited 22× · PMID 37071328 · DOI 10.1007/s44228-023-00041-x
  4. Targeting regulated cell death pathways in acute myeloid leukemia.
    Garciaz S, Miller T, Collette Y, Vey N. · · 2023 · cited 19× · PMID 37065864 · DOI 10.20517/cdr.2022.108
  5. Emerging drugs targeting cellular redox homeostasis to eliminate acute myeloid leukemia stem cells.
    Costa RGA, Silva SLR, Dias IRSB, Oliveira MS, et al · · 2023 · cited 16× · PMID 37031536 · DOI 10.1016/j.redox.2023.102692
  6. Targeting Apoptosis in AML: Where Do We Stand?
    Krawiec K, Strzałka P, Czemerska M, Wiśnik A, et al · · 2022 · cited 14× · PMID 36291779 · DOI 10.3390/cancers14204995
  7. Unraveling Venetoclax Resistance: Navigating the Future of HMA/Venetoclax-Refractory AML in the Molecular Era.
    Chatzilygeroudi T, Karantanos T, Pappa V. · · 2025 · cited 9× · PMID 40361510 · DOI 10.3390/cancers17091586
  8. Molecular Regulation of SASP in Cellular Senescence: Therapeutic Implications and Translational Challenges.
    Klepacki H, Kowalczuk K, Łepkowska N, Hermanowicz JM. · · 2025 · cited 8× · PMID 40643463 · DOI 10.3390/cells14130942

Verify or expand the search:

Other trials of Decitabine

Trials testing the same drug.

Other recruiting trials for Recurrent Acute Myeloid Leukemia

Currently open trials in the same condition.

Other City of Hope Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05222984.

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