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NCT06652685
Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Phase 2 trial testing D5-PBCR(-) IA arm in Acute Myeloid Leukemia (AML) in 218 participants. Not yet recruiting.
31 October 2026
Quick facts
| Lead sponsor | Ruijin Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 218 |
| Start date | 30 October 2024 |
| Primary completion | 31 October 2026 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- D5-PBCR(-) IA arm — full drug profile →
- D5-PBCR(+) IA+Venetoclax arm — full drug profile →
Conditions studied
- Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
Sponsor
Ruijin Hospital
Who can join
Adults 18 to 59, any sex, with Acute Myeloid Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib. Subjects will receive standard intensive chemotherapy during induction and consolidation. Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). Venetoclax will be added in D5-PBCR positive subjects. For subjects with FLT3 mutations, Gilteritinib will be combined. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations (ELN risk) and MRD status to receive specific consolidation therapy after the induction therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06652685
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Myeloid Leukemia (AML)
Currently open trials in the same condition.
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- NCT06707493 — Ivosidenib as Post-HSCT Maintenance for AML · Phase 2 · recruiting
- NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia · active not recruiting
Other Ruijin Hospital trials
Trials by the same sponsor.
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- NCT07511114 — A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyp · Phase 3 · not yet recruiting
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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 NCT06652685 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ruijin Hospital
- Last refreshed: 22 October 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/NCT06652685.
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