Actively Recruiting
IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML
Led by National Research Center for Hematology, Russia · Updated on 2024-05-17
198
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
N
National Research Center for Hematology, Russia
Lead Sponsor
S
St. Petersburg State Pavlov Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with primary refractory acute myeloid leukemia
- Diagnosed with early relapsed acute myeloid leukemia
- Signed informed consent to participate in the study
You will not qualify if you...
- Late relapsed acute myeloid leukemia
- Isolated extramedullary relapse
- MRD relapse without bone marrow relapse of AML
- Acute promyelocytic leukemia
- Previous refractoriness or loss of response during venetoclax therapy
- Previous allogeneic hematopoietic stem cell transplantation
- Pregnancy or lactation
- Refusal to use effective contraception if of reproductive potential
- Lack of signed informed consent
- Failure to follow the study protocol
- Participation in another clinical trial
- Uncontrolled infections
- ECOG performance status 3 or higher
- History of other malignancies within past 3 years except certain low-risk cancers
- Chronic kidney disease with GFR 30 ml/min/1.73 m2 or less
- Severe cardiac conditions including uncontrolled hypertension, unstable angina, recent myocardial infarction, heart failure stages IIb-III, or significant ECG abnormalities
- Cirrhosis class B or C by Child-Pugh classification
- Elevated liver function tests above specified limits
- Major surgery within 14 days before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Research Center for Hematology
Moscow, Russia, 125167
Actively Recruiting
Research Team
A
Anastasia Kashlakova, MD
CONTACT
E
Elena Parovichnikova, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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