BridgeMD
VEN-R DASA-IPC 2022-067 Evaluation of DASATINIB monotherapy efficacy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE
EU CTIS ID: 2023-505846-24-00
What this study is testing
The main objective is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VEN-AZA therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)
- Age ≥ 18 years
- ECOG ≤3
- VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration
- Signed informed consent form
- Affiliation to a social security system, or beneficiary of such a system
You likely can't join if
- Central nervous system involvement
- No efficient contraception for the women of childbearing age
- Emergency situation person or not able to express his/her informed consent
- Patient eligible to a targeted therapy having a market authorization
- Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)
- Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons
See the full eligibility criteria
- Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)
- Age ≥ 18 years
- ECOG ≤3
- VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration
- Signed informed consent form
- Affiliation to a social security system, or beneficiary of such a system
- Central nervous system involvement
- No efficient contraception for the women of childbearing age
- Emergency situation person or not able to express his/her informed consent
- Patient eligible to a targeted therapy having a market authorization
- Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)
- Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons
- Heart failure defined as one of the following criteria: a. Stage III or IV heart failure according to the New York Heart Association Classification including pre-existing clinically significant arrhythmia, congestive heart failure or cardiomyopathy. b. Angina pectoris ≤ 3 months before the start of the experimental treatment. c. Acute myocardial infarction ≤ 3 months before the start of the experimental treatment. d. Other clinically significant heart disease (e.g. uncontrolled hypertension, history of labile hypertension or history of poor adherence with an antihypertensive medication). e. Left ventricle ejection fraction < 50 %.
- Liver failure defined as: a. Liver enzymes: ALT and/or AST ≤ 2.5 of upper limit of normal except if the increased ALT/AST levels are related to AML. b. Total bilirubin ≤ 3 x the upper limit of normal except in case of Gilbert’s syndrome.
- Kidney failure defined as creatinine clearance ≥45 ml/min (estimated by the diet in the renal disease equation or measured by using a 24-hour urine collection).
- Contraindication to DASATINIB: a. Patients with a congenital long QT syndrome, patients treated with antiarrhythmic drugs or other medications that may cause long QT syndrome. b. Current therapy using strong inhibitors of CYP3A4 (ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice). c. Patients with rare hereditary fructose intolerance, glucose-lactose malabsorption or sucrase-isomaltase deficiency.
- Positive for HIV, Hepatitis B or C
- Pregnant or breastfeeding woman
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.