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| Name | Class |
|---|---|
| St. Petersburg State Pavlov Medical University | OTHER |
| Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive arm | Active Comparator | Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to intensive chemotherapy courses |
|
| Low-intensive arm | Active Comparator | Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to low intensity courses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive therapy | Other | Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of achieving CR in patients with R/R AML, depending on the use of high or low intensity treatment regimens | Assessment method: Chi-square test | 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 |
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Inclusion Criteria:
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:
Cirrhosis classes B-C according to the Child-Pugh classification
Increased liver function tests above the following values:
Major surgical interventions underwent less than 14 days before inclusion in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia Kashlakova, MD | Contact | +79629087553 | kashlakova.a.i@gmail.com | |
| Elena Parovichnikova, MD | Contact | +74956122123 | parovichnikova.e@blood.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center for Hematology | Recruiting | Moscow | 125167 | Russia |
Each center participating in the study includes patients and fills CRF forms separately.
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Patients who could potentially undergo courses of intensive chemotherapy ("fit") are randomisedrandomized into two arms:
If remission of the AML has been achieved, patients in both groups undergo alloHSCT as soon as possible.
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| Low intensity therapy |
| Other |
Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven) |
|
Assessment method: Chi-square test |
| 3 months |
| Cumulative incidence of alloHSCT in patients with R/R AML, depending on the use of high or low intensity treatment regimens | Evaluation method: cumulative frequency curves and Gray's test | 2 years |
| Toxicity of high versus low intensity regimens | Evaluation method: Chi-square test, parametric/nonparametric tests for means Variables to be evaluated:
| 3 months |
| OS over the entire duration of the study, including follow-up after alloHSCT | Evaluation method: Kaplan-Meier curves and log-rank test | 2 years |
| RFS in patients with R/R AML when achieving remission before alloHSCT, depending on the use of high or low intensity treatment regimens | Evaluation method: Kaplan-Meier curves and log-rank test | 2 years |
| Relapse incidence in patients with R/R AML when achieving remission before performing alloHSCT, depending on the use of high or low intensity treatment regimens | Evaluation method: cumulative frequency curves and Gray's test | 2 years |
| EFS of patients with R/R AML depending on the use of high or low intensity regimens, regardless of alloHSCT | Evaluation method: Farington-Manning test, not censored for transplantation | 2 years |
| Statistics on discontinued participation in the protocol and premature withdrawal from the study | Assessment method: Chi-square test | 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |