Clinical trial · Interventional
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients
NCT07511062CI-TRIAL-00107416not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| TP53 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axatilimab | Drug | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axatilimab+Decitabine+Venetoclax
- interventionNames
- Drug: Decitabine
- Drug: Venetoclax
- Drug: Axatilimab
Primary outcomes (2)
- measure
- Phase 2 Dose Level determination
- timeFrame
- 1 year
- description
- To find the recommended phase 2 dose (RP2D) of axatilimab when combined with decitabine and venetoclax by recording adverse events based on the CTCAE v.5.
- measure
- Estimation of MRD-negative complete remission
- timeFrame
- 2 months
- description
- To estimate the MRD-negative complete remission rate after 1-2 cycles of induction chemotherapy with decitabine and venetoclax by conducing bone marrow biopsies and disease response assessments after induction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * MDS/AML or AML with a TP53 mutation or deletion, defined as: * greater than or equal to 10% AND (one of the following): * presence of a TP53 mutation * presence of a TP53 deletion by FISH * positive TP53 staining on IHC of diagnostic bone marrow * Either untreated or first salvage (primary refractory or first relapse) Exclusion Criteria: * KPS \<60 * active uncontrolled infection * history of HIV or active HBV or HBC infection * currently active second malignancy * calculated CrCl \<40mL/min * AST and/or ALT and/or direct bilirubin \>3x ULN * cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias * history of acute or chronic pancreatitis, history of myositis * known leukemia involvement of CNS * hematopoietic stem cell transplantation within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade 2+ related to the transplant * active acute or chronic GVHD requiring immunosuppressive treatment
References
Publications (34)
- RESULTWolff D, Cutler C, Lee SJ, Pusic I, Bittencourt H, White J, Hamadani M, Arai S, Salhotra A, Perez-Simon JA, Alousi A, Choe H, Kwon M, Bermudez A, Kim I, Socie G, Chhabra S, Radojcic V, O'Toole T, Tian C, Ordentlich P, DeFilipp Z, Kitko CL; AGAVE-201 Investigators. Axatilimab in Recurrent or Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2024 Sep 19;391(11):1002-1014. doi: 10.1056/NEJMoa2401537. PMID 39292927
- RESULTKitko CL, Arora M, DeFilipp Z, Zaid MA, Di Stasi A, Radojcic V, Betts CB, Coussens LM, Meyers ML, Qamoos H, Ordentlich P, Kumar V, Quaranto C, Schmitt A, Gu Y, Blazar BR, Wang TP, Salhotra A, Pusic I, Jagasia M, Lee SJ. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study. J Clin Oncol. 2023 Apr 1;41(10):1864-1875. doi: 10.1200/JCO.22.00958. Epub 2022 Dec 2. PMID 36459673
- RESULTAlexander KA, Flynn R, Lineburg KE, Kuns RD, Teal BE, Olver SD, Lor M, Raffelt NC, Koyama M, Leveque L, Le Texier L, Melino M, Markey KA, Varelias A, Engwerda C, Serody JS, Janela B, Ginhoux F, Clouston AD, Blazar BR, Hill GR, MacDonald KP. CSF-1-dependant donor-derived macrophages mediate chronic graft-versus-host disease. J Clin Invest. 2014 Oct;124(10):4266-80. doi: 10.1172/JCI75935. Epub 2014 Aug 26. PMID 25157821
- RESULTLemmon MA, Schlessinger J. Cell signaling by receptor tyrosine kinases. Cell. 2010 Jun 25;141(7):1117-34. doi: 10.1016/j.cell.2010.06.011. PMID 20602996
- RESULTRosnet O, Birnbaum D. Hematopoietic receptors of class III receptor-type tyrosine kinases. Crit Rev Oncog. 1993;4(6):595-613. PMID 7506935
- RESULTXu L, Xie X, Li X, Duan W, Qiu L, Liu H, Luo Y. Inflammatory level under different p53 mutation status and the regulation role of curcumin in tumor microenvironment. Immunobiology. 2022 Mar;227(2):152177. doi: 10.1016/j.imbio.2022.152177. Epub 2022 Jan 7. PMID 35030341