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OncoMatch/Clinical Trials/NCT06418776

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

Is NCT06418776 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for refractory acute myeloid leukemia.

Phase 3RecruitingNational Research Center for Hematology, RussiaNCT06418776Data as of May 2026

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).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: BCL2 inhibitor (venetoclax)

Previous refractoriness or loss of response during ongoing venetoclax therapy

Cannot have received: allogeneic hematopoietic stem cell transplant

Previous alloHSCT

Lab requirements

Kidney function

Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (CKD-EPI Creatinine Equation)

Liver function

Cirrhosis classes B-C (Child-Pugh); Total bilirubin > 1.5x normal; AST, ALT > 10x normal

Cardiac function

Uncontrolled arterial hypertension; stable angina III-IV; unstable angina/myocardial infarction <6 months; heart failure IIb-III, NYHA III-IV; uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0); clinically significant ECG abnormalities

Cirrhosis classes B-C according to the Child-Pugh classification; Total bilirubin > 1.5 above the normal range; AST, ALT > 10 above the normal range; Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (CKD-EPI Creatinine Equation); Severe cardiac pathology: uncontrolled arterial hypertension; stable angina III-IV functional classes; unstable angina and/or myocardial infarction less than 6 months before inclusion in the study; heart failure stages IIb-III, NYHA functional classes III-IV; uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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