Adults 15 to 65, any sex, with Advanced Cancers or Lymphoma. 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.
Frequency of DLTPrimary· Enrollment up to day 30 post transplant for each dosing cohort
Maximum tolerated dose (MTD) of azacitidine based on DLT was defined as any Grade 4 nonhematologic and noninfectious toxicity or any grade 3 mucositis or skin toxicity lasting \> 3 days at peak severity. For dose finding, the continunal reassessment method was used with a target DLT probability per cohort of 25%. Azacitidine doses were chosen adaptively for sucessive cohorts with a minimum size of 2 patients. Toxicity scoring followed the National Cancer Institute Common Toxicity Criteria, version 3.
Group
Value
95% CI
Azacitidine Dose Level 1
16
Azacitidine Dose Level 2
28
Azacitidine Dose Level 3
40
Participants With Event-free Survival (EFS)Primary· Enrollment up to 100 days post transplant.
EFS is defined as the time from transplantation to either relapse, second tumors, or death, whichever occurred first, or last contact. EFS was analzyed by the individual disease groups rather than the cohort dose levels.
Group
Value
95% CI
DLBCL
17
Hodgkin Lymphoma
16
T-cell NHL
7
Other B-cell Lymphoma
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 100 Days post autologous transplant..
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 find the highest tolerable dose of azacitidine that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want to learn about the safety and level of effectiveness of this combination.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07508982 — Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML
· Phase 1, PHASE2
· not yet recruiting
NCT05554419 — Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Tr
· Phase 2
· not yet recruiting
NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML
· NA
· not yet recruiting
NCT07469046 — VAH vs VA in Newly Diagnosed Elderly AML
· Phase 3
· not yet recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 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: 27 January 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/NCT01983969.