IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Research Center for Hematology, Russia
About this trial
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).
Eligibility criteria
Qualifiers
Age ≥ 18 years;
Primary refractory AML;
Early relapsed AML;
A signed informed consent to participate in the study.
Disqualifiers
Late relapsed AML;
Isolated extramedullary relapse;
MRD relapse without development of bone marrow relapse of AML;
Acute promyelocytic leukemia;
Trial design
Treatments tested in this trial
- Intensive therapy
- Low intensity therapy
Treatment groups
198 Participants
are divided into 2 treatment groupsSponsors and collaborators
National Research Center for Hematology, Russia
Lead sponsor
St. Petersburg State Pavlov Medical University
Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Collaborator
Source ClinicalTrials.gov