Health TrialsbyHealthPanel

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

ConditionsRefractory Acute Myeloid LeukemiaEarly Relapses of Acute Myeloid Leukemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Intensive therapy

    Other intervention

    Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito)

  • Low intensity therapy

    Other intervention

    Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven)

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Intensive armActive comparator 1 intervention
Group B: Low-intensive armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Event-free survival of patients with R/R AML depending on the use of high or low intensity therapy exposure before alloHSCT

Evaluation method: Kaplan-Meier curves and log-rank test, censored for transplantation

Time frame
2 years

Secondary outcomes

1

Probability of achieving CR in patients with R/R AML, depending on the use of high or low intensity treatment regimens

Assessment method: Chi-square test

Time frame
3 months
2

Probability of achieving a response (CR, CR with incomplete hematological recovery, morphologic leukemia- free state, partial remission) in patients with R/R AML, depending on the use of high or low intensity treatment regimens

Assessment method: Chi-square test

Time frame
3 months
3

Cumulative incidence of alloHSCT in patients with R/R AML, depending on the use of high or low intensity treatment regimens

Evaluation method: cumulative frequency curves and Gray's test

Time frame
2 years
4

Toxicity of high versus low intensity regimens

Evaluation method: Chi-square test, parametric/nonparametric tests for means Variables to be evaluated: 1. Maximum degree and duration of neutropenia and/or thrombocytopenia; 2. Development of uncontrolled/life-threatening infectious complications; 3. Development of life-threatening hemorrhagic complications; 4. Development of severe organ failure.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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