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Trial Title:
IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML
NCT ID:
NCT06418776
Condition:
Refractory Acute Myeloid Leukemia
Early Relapses of Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Recurrence
Conditions: Keywords:
Acute myeloid leukemia
Relapse of AML
Refractory AML
Allogeneic Stem Cell Transplantation
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Intensive therapy
Description:
Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito)
Arm group label:
Intensive arm
Intervention type:
Other
Intervention name:
Low intensity therapy
Description:
Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven)
Arm group label:
Low-intensive arm
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Research Center for Hematology
Address:
City:
Moscow
Zip:
125167
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Elena Parovichnikova, MD
Phone:
+74956122361
Email:
director@blood.ru
Contact backup:
Last name:
Anastasia Kashlakova, MD
Phone:
+74956124592
Email:
kashlakova.a@blood.ru
Start date:
April 1, 2024
Completion date:
May 2029
Lead sponsor:
Agency:
National Research Center for Hematology, Russia
Agency class:
Other
Collaborator:
Agency:
St. Petersburg State Pavlov Medical University
Agency class:
Other
Collaborator:
Agency:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Agency class:
Other
Source:
National Research Center for Hematology, Russia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06418776
