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

NCT06418776 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-05-17

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    collaborator OTHER

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    collaborator OTHER

  • National Research Center for Hematology, Russia

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-04-30
Completion
2029-05-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418776 on ClinicalTrials.gov