NCT06418776

IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML

A Prospective Multicenter Randomized Clinical Trial on the Treatment of Patients With Refractory or Early Relapses of Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the efficacy and toxicity of high versus low intensity therapy options in patients with refractory forms and early relapses of acute myeloid leukemia (R/R AML) who are scheduled for allogeneic hematopoietic stem cell transplantation (alloHSCT).

Conditions

• Refractory Acute Myeloid Leukemia
• Early Relapses of Acute Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Intensive therapy	Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito)
OTHER	Low intensity therapy	Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven)

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-04-01
• Completion: 2029-05-01
• First posted: 2024-05-17
• Last updated: 2024-05-17

Locations

1 site across 1 country: Russia