Comparing high and low intensity therapies for relapsed or refractory acute myeloid leukemia

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

This study is testing whether high-intensity or low-intensity therapies work better for adults with relapsed or hard-to-treat acute myeloid leukemia who are getting ready for a stem cell transplant.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Research Center for Hematology, Russia (network)
• Locations: 1 site (Moscow)
• Trial ID: NCT06418776 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and toxicity of high versus low intensity therapy options in patients with refractory acute myeloid leukemia (AML) or early relapses of AML who are scheduled for allogeneic hematopoietic stem cell transplantation. The study aims to determine which treatment approach yields better outcomes for these patients. Participants must be at least 18 years old and provide informed consent to join the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with primary refractory AML or early relapsed AML.

Not a fit: Patients with late relapsed AML or those who have previously undergone allogeneic stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with relapsed or refractory AML.

How similar studies have performed: Other studies have shown promise in evaluating treatment intensities for AML, but this specific approach is being tested in a pragmatic setting, making it a novel contribution.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years;
* Primary refractory AML;
* Early relapsed AML;
* A signed informed consent to participate in the study.

Exclusion Criteria:

* Late relapsed AML;
* Isolated extramedullary relapse;
* MRD relapse without development of bone marrow relapse of AML;
* Acute promyelocytic leukemia;
* Previous refractoriness or loss of response during ongoing venetoclax therapy;
* Previous alloHSCT;
* Pregnancy and/or lactation period;
* Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study;
* Lack of signed informed consent to participate in the study;
* Failure of the subject to follow the study protocol;
* Participation in any other clinical trial;
* Uncontrolled infectious complications;
* ECOG ≥ 3;
* History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years;
* Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (according to the CKD-EPI Creatinine Equation);
* Severe cardiac pathology:

  1. uncontrolled arterial hypertension;
  2. stable angina III-IV functional classes;
  3. unstable angina and/or myocardial infarction less than 6 months before inclusion in the study;
  4. heart failure stages IIb-III, NYHA functional classes III-IV
  5. uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities.
* Cirrhosis classes B-C according to the Child-Pugh classification
* Increased liver function tests above the following values:

  1. Total bilirubin \> 1,5 above the normal range;
  2. AST, ALT \> 10 above the normal range.
* Major surgical interventions underwent less than 14 days before inclusion in the study.

Where this trial is running

Moscow

• National Research Center for Hematology — Moscow, Russia (RECRUITING)

Study contacts

• Study coordinator: Anastasia Kashlakova, MD

Conditions: Refractory Acute Myeloid Leukemia, Early Relapses of Acute Myeloid Leukemia, Acute myeloid leukemia, Relapse of AML, Refractory AML, Allogeneic Stem Cell Transplantation