Acute Myeloid LeukemiaPhase 2VEN-R DASANCT06055621
Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
A Phase 2 study testing Dasatinib in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2024to Jan 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient eligible to a targeted therapy having a market authorization
- Central nervous system involvement
- Heart failure
- Liver failure
- Kidney failure
- Contraindication to DASATINIB
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Dasatinib
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Daily orally administration of DASATINIB
| Study group | Role | What they receive |
|---|---|---|
| DASATINIB | Experimental | Not described Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (6)
response rates
Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.
Measured: 3 months
Time to response
Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)
Measured: 3 months
Duration of relapse-free period
Duration of relapse-free period (time between the response time and the relapse)
Measured: 3 months
Event-free survival
Event-free survival (EFS, time between start of treatment and relapse, no response or death)
Measured: 3 months
Overall survival
Overall survival (duration of survival from the start of the treatment)
Measured: 3 months
Occurrence of Adverse Events
Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start22 May 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Why it stopped: Planned interim analyse
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055621
- Sponsor's protocol ID
- VEN-R DASA-IPC 2022-067
- Acronym
- VEN-R DASA
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
- ClinicalTrials.gov ID
- NCT06055621
- Acronym / sponsor ID
- VEN-R DASA / VEN-R DASA-IPC 2022-067
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Planned interim analyse
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DASATINIB | Experimental | Drug: Dasatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Patient eligible to a targeted therapy having a market authorization
- Central nervous system involvement
- Heart failure
- Liver failure
- Kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibDaily orally administration of DASATINIB | Drug | DASATINIB |
Primary outcome
tumor response
Time frame: 2 months
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.
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.