An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
TerminatedPhase 1, PHASE2Results postedLast updated 22 October 2020
What this trial tests
Phase 1, PHASE2 trial testing Dasatinib in Leukemia in 32 participants. Terminated before completion.
18 and older, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Ph I Study: Maximum Tolerated Dose (MTD) DasatinibPrimary· End of first 28-day cycle
Maximum tolerated dose (MTD) defined as highest dose at which 0 of 3 or \</= 1/6 participant experience a first cycle dose limiting toxicity (DLT).
Group
Value
95% CI
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
NA
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
NA
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
140
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
140
Number of Participants With Hematologic Responses During First 3 Months of TreatmentSecondary· 3 months
Number of participants with hematologic response (HR) to therapy during first 3 months of combination dasatinib and decitabine therapy, where HR defined as any hematologic response observed during the first 3 months of treatment. Overall Hematologic Response (OHR) is defined as complete hematologic response (CHR), no evidence of leukemia (NEL) or minor hematologic response (MiHR)
Group
Value
95% CI
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
3
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
1
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
5
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
4
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
3
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
3
Overall SurvivalSecondary· Up to seven years
Overall Survival will be measured from the date treatment is started to the date of death or last follow-up.
Group
Value
95% CI
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
12.0
0.6 – 36.8
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
7.0
2.3 – 82.8
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
57.8
0.9 – 79.4
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
58.2
3.6 – 58.2
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
62.0
6.0 – 62.0
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
37.5
9.6 – 37.5
Duration of ResponseSecondary· up to seven years
Duration of Response will be measured from the date the given response is achieved to the date the response is first known to be lost
Group
Value
95% CI
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
36.8
1.2 – 36.8
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
82
82 – 82
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
57.8
.09 – 79.4
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
58
37 – 58
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
61
1.5 – 61.0
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
37
30 – 37
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to seven years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this clinical research study is to learn if combining Sprycel (dasatinib) and Dacogen (decitabine) can help to control Chronic Myeloid Leukemia (CML). The dose level of decitabine will also be studied.
Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia.
Decitabine is designed to affect the mechanism that cells use to control the expression of certain genes, some of which are important in the progression of CML.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of patients with certain types of CML.
Decitabine is FDA approved for the treatment of patients with myelodysplastic syndrome.
The combination of these drugs to treat CML is investigational.
Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07269470 — Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly
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NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction
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NCT07144293 — Improving Physical Ability and Cellular Senescence Elimination in HIV
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NCT05751044 — HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relaps
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· recruiting
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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: 22 October 2020
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/NCT01498445.