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Recruiting NCT06055621

Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dasatinib.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Overview

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.

Interventions

  • Drug Dasatinib
    Daily orally administration of DASATINIB

Primary outcome measures

  • tumor response [Time frame: 2 months]
Secondary outcome measures (6)
  • response rates [Time frame: 3 months]
  • Time to response [Time frame: 3 months]
  • Duration of relapse-free period [Time frame: 3 months]
  • Event-free survival [Time frame: 3 months]
  • Overall survival [Time frame: 3 months]
  • Occurrence of Adverse Events [Time frame: 3 months]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • Patient eligible to a targeted therapy having a market authorization
  • Central nervous system involvement
  • Heart failure
  • Liver failure
  • Kidney failure
  • Contraindication to DASATINIB
  • Positive for HIV (detectable viral load), Hepatitis B or C
  • Pregnant or breastfeeding woman
  • No efficient contraception for the women of childbearing age
  • Emergency situation person or not able to express his/her informed consent
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Institut Paoli Calmettes — Marseille

Identifiers

NCT: NCT06055621 · VEN-R DASA-IPC 2022-067

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗