Last reviewed · How we verify
NCT05433532
Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
Phase 2 trial testing Azacitidine in Philadelphia Chromosome in 20 participants. Completed in 13 April 2024.
13 April 2024
Quick facts
| Lead sponsor | The First Affiliated Hospital of Soochow University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 May 2022 |
| Primary completion | 13 April 2024 |
| Estimated completion | 13 April 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Azacitidine (azacitidine) — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
- Flumatinib — full drug profile →
Conditions studied
- Philadelphia Chromosome — all drugs for Philadelphia Chromosome →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
- Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
Sponsor
The First Affiliated Hospital of Soochow University
Who can join
Adults 18 to 65, any sex, with Philadelphia Chromosome or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of azacitidine，venetoclax，and flumatinib in newly diagnosed Philadelphia chromosome-positive acute leukemia and accelerated phase or blast phase chronic myeloid leukemia patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Emerging Role of Venetoclax-Based Treatments in Acute Lymphoblastic Leukemia.
Aumann S, Shaulov A, Haran A, Gross Even-Zohar N, et al · · 2022 · cited 30× · PMID 36142863 · DOI 10.3390/ijms231810957 -
Chemotherapy-free treatment of VAF induces early and deep molecular response in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia: a prospective, single-center, single-arm, phase 2 trial
Li M, Cui Q, Qiu H, Liu L, et al · · 2024 · DOI 10.21203/rs.3.rs-4589148/v1
Verify or expand the search:
- PubMed search for NCT05433532
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azacitidine
Trials testing the same drug.
- 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
Other recruiting trials for Philadelphia Chromosome
Currently open trials in the same condition.
- NCT06220487 — A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With New · Phase 2 · recruiting
Other The First Affiliated Hospital of Soochow University trials
Trials by the same sponsor.
- NCT07350863 — U69-CART-Cells For R/R T-ALL · Phase 1 · recruiting
- NCT06985498 — Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL · Phase 2 · not yet recruiting
- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
- NCT07511426 — U96-CAR-T-Cells For R/R B-ALL · Phase 1 · recruiting
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 NCT05433532 (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 The First Affiliated Hospital of Soochow University
- Last refreshed: 25 April 2024
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/NCT05433532.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing