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NCT04188405
Decitabine, Venetoclax, and Ponatinib for the Treatment of Philadelphia Chromosome-Positive Acute Myeloid Leukemia or Myeloid Blast Phase or Accelerated Phase Chronic Myelogenous Leukemia
Phase 2 trial testing Decitabine in Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive in 20 participants. Participants enrolled and being followed up; not accepting new ones.
30 November 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 17 May 2020 |
| Primary completion | 30 November 2026 |
| Estimated completion | 30 November 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Decitabine (decitabine) — full drug profile →
- Ponatinib — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
Conditions studied
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive — all drugs for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive — all drugs for Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive →
- Recurrent Acute Myeloid Leukemia — all drugs for Recurrent Acute Myeloid Leukemia →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well the combination of decitabine, venetoclax, and ponatinib work for the treatment of Philadelphia chromosome-positive acute myeloid leukemia or myeloid blast phase or accelerated phase chronic myelogenous leukemia. Drugs used in chemotherapy such as 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. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine, venetoclax, and ponatinib may help to control Philadelphia chromosome-positive acute myeloid leukemia or myeloid blast phase or accelerated phase chronic myelogenous leukemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181 -
Resistance to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia-From Molecular Mechanisms to Clinical Relevance.
Alves R, Gonçalves AC, Rutella S, Almeida AM, et al · · 2021 · cited 112× · PMID 34638304 · DOI 10.3390/cancers13194820 -
Venetoclax and BCR-ABL Tyrosine Kinase Inhibitor Combinations: Outcome in Patients with Philadelphia Chromosome-Positive Advanced Myeloid Leukemias.
Maiti A, Franquiz MJ, Ravandi F, Cortes JE, et al · · 2020 · cited 64× · PMID 32289808 · DOI 10.1159/000506346 -
Mechanisms of Resistance and Implications for Treatment Strategies in Chronic Myeloid Leukaemia.
Poudel G, Tolland MG, Hughes TP, Pagani IS. · · 2022 · cited 44× · PMID 35884363 · DOI 10.3390/cancers14143300 -
The application of BH3 mimetics in myeloid leukemias.
Parry N, Wheadon H, Copland M. · · 2021 · cited 37× · PMID 33637708 · DOI 10.1038/s41419-021-03500-6 -
Impact of frontline treatment approach on outcomes of myeloid blast phase CML.
Saxena K, Jabbour E, Issa G, Sasaki K, et al · · 2021 · cited 34× · PMID 34130720 · DOI 10.1186/s13045-021-01106-1 -
Treatment of blast phase chronic myeloid leukaemia: A rare and challenging entity.
Copland M. · · 2022 · cited 31× · PMID 35866251 · DOI 10.1111/bjh.18370 -
Targeting Chronic Myeloid Leukemia Stem/Progenitor Cells Using Venetoclax-Loaded Immunoliposome.
Houshmand M, Garello F, Stefania R, Gaidano V, et al · · 2021 · cited 25× · PMID 33804056 · DOI 10.3390/cancers13061311
Verify or expand the search:
- PubMed search for NCT04188405
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04188405 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 20 November 2025
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/NCT04188405.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing