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The goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy.
Participants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASATINIB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Daily orally administration of DASATINIB |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor response | Objective response rate after 2 cycles of 28 days DASATINIB defined as the rate of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) according to ELN 2022 criteria. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| response rates | Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria. | 3 months |
| Time to response | Time to response (time between the start of the treatment until achievement of the CR, CRi or PR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihane PAKARANOUNI, PharmD,PhD | Contact | +33491223778 | drci.up@ipc.unicancer.fr | |
| Laurie-Anne GOUTY, PhD | Contact | 33491223778 | drci.up@ipc.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Recruiting | Marseille | France |
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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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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 3 months |
| Duration of relapse-free period | Duration of relapse-free period (time between the response time and the relapse) | 3 months |
| Event-free survival | Event-free survival (EFS, time between start of treatment and relapse, no response or death) | 3 months |
| Overall survival | Overall survival (duration of survival from the start of the treatment) | 3 months |
| Occurrence of Adverse Events | Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction | 3 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |