60 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.
Maximum Tolerated Dose (MTD) of Vosaroxin in Combination With DecitabinePrimary· 21 days
Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which \<33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5%
Group
Value
95% CI
Phase I MTD Vosaroxin
70
Participants With a ResponseSecondary· 21 days
A Response is defined as: Complete response (CR) + Complete response without platelet recovery (CRp) + CR with insufficient hematological recovery (platelets or neutrophils (CRi). CR is Neutrophil count 2: 1.0 x 10\^9/L, platelet count 2: 100 x 10\^9/L and bone marrow aspirate and biopsy: S5% blasts. CRp is same as CR but with Platelets \< 100 x 10\^/L. CRi is same as CR but platelets \< 100 x 10(/L or neutrophils \< 1 x 10\^9.
Group
Value
95% CI
Phase I MTD Vosaroxin
7
Vosaroxin + Decitabine
42
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years 11 months.
Reporting threshold: 0%.
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 the combination of vosaroxin and decitabine can help to control AML or MDS. The safety of these drugs will also be studied.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03338348 — Study of Vosaroxin With Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
· Phase 2
· completed
NCT01980056 — Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
· Phase 1, PHASE2
· completed
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Trials by the same sponsor.
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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: 9 February 2022
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/NCT01893320.