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NCT06652685

Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Not yet recruiting Phase 2 Last updated 22 October 2024
What this trial tests

Phase 2 trial testing D5-PBCR(-) IA arm in Acute Myeloid Leukemia (AML) in 218 participants. Not yet recruiting.

Timeline
30 October 2024
Primary endpoint
31 October 2026
30 June 2027

Quick facts

Lead sponsorRuijin Hospital
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment218
Start date30 October 2024
Primary completion31 October 2026
Estimated completion30 June 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Acute Myeloid Leukemia (AML)

Currently open trials in the same condition.

Other Ruijin Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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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