NCT06418776 IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML
| NCT ID | NCT06418776 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Research Center for Hematology, Russia |
| Condition | Refractory Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 198 participants in total. It began in 2024-04-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06418776 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Refractory Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06418776 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 198 participants.
Is NCT06418776 currently recruiting?
Yes, NCT06418776 is actively recruiting participants. Contact the research team at kashlakova.a.i@gmail.com for enrollment information.
Where is the NCT06418776 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06418776 clinical trial?
NCT06418776 is sponsored by National Research Center for Hematology, Russia. The trial plans to enroll 198 participants.
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