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

NCT06418776 | Recruiting Phase 3 DMC

• 1 other identifier: IMPACT-AML
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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).

Conditions

Refractory Acute Myeloid Leukemia; Early Relapses of Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia; Relapse of AML; Refractory AML; Allogeneic Stem Cell Transplantation

Outcome Measures

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

  2 years

Secondary Outcomes (9)

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

  3 months

• 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

  3 months

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

  2 years

• Toxicity of high versus low intensity regimens

  3 months

• OS over the entire duration of the study, including follow-up after alloHSCT

  2 years

Study Arms (2)

Intensive arm

ACTIVE COMPARATOR

Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to intensive chemotherapy courses

Other: Intensive therapy

Low-intensive arm

ACTIVE COMPARATOR

Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to low intensity courses

Other: Low intensity therapy

Interventions

Intensive therapy OTHER

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

Intensive arm

Low intensity therapy OTHER

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

Low-intensive arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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);

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead
• 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

Study Sites (1)

National Research Center for Hematology

Moscow, 125167, Russia

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Anastasia Kashlakova, MD

CONTACT

+79629087553; kashlakova.a.i@gmail.com

Elena Parovichnikova, MD

CONTACT

+74956122123; parovichnikova.e@blood.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General director of National Medical Research Center for Hematology

Model Details: Patients who could potentially undergo courses of intensive chemotherapy ("fit") are randomisedrandomized into two arms: * Arm 1 - intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito) * Arm 2 - low intensity therapy (Aza/Dac/LDARA-C + Ven) Randomization determines the intensity of the program, but not the specific therapeutic regimen. The treatment regimen is selected by the investigators based on accepted clinical practice, the availability of appropriate drugs at the participating centers, etc., after randomization. If a patient has FLT3 gene mutations, one of the available kinase inhibitors must be added to therapy: midostaurin, gilteritinib, sorafenib. If remission of the AML has been achieved, patients in both groups undergo alloHSCT as soon as possible.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 17, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)