Adult Patients With Adverse Risk Acute Myeloblastic LeukemiaPhase 1DARALAMNCT05749276
Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine or CPX-351) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)
A Phase 1 study testing Darzalex in people with Adult Patients With Adverse Risk Acute Myeloblastic Leukemia, run by Nantes University Hospital at 1 site in France.
Trial summary
To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine or CPX-351 in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Adult Patients With Adverse Risk Acute Myeloblastic Leukemia
- What is being tested?
- Darzalex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2025to 6 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 60 ans
- Poor prognosis AML defined according to the following criteria:1. For first-line AML:intermediate or unfavorable risk according to ELN 2022 2.for Relapsed AML:regardless of the ELN risk group
- ECOG <= 2
- Patient eligible for intensive chemotherapy
- Who provide their written informed consent
- Liver workup: transaminases < 3x normal, bilirubin < 1.5 X normal
- Creatinine clearance > 60ml/mn
- LVEF >= 50%.
Who cannot join
- Patients with FLT3 ITD or TKD mutation
- Patients with tuberculosis
- Patients with documented active infection with COVID 19
- Patients with hereditary fructose intolerance (HFI)
- Uncontrolled infection
- Active or past infection with Hep B, C or HIV+
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- Not Affiliated with French social security system or no beneficiary from such system
- Pregnant women or patients who cannot take contraception ( contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 6 months after the last injection of DARATUMUMAB is not eligible for inclusion.
- Breastfeeding women
- Minors
- Adults under guardianship, curatorship or safeguard of justice
- Hypersensitivity to any of the active ingredients or excipients
- Patients with significant cardiovascular pathology including any of the following: myocardial infarction within 6 months prior to study entry, unstabilized coronary artery disease, uncontrolled hypertension, congestive heart failure.
- Patient with disease requiring systemic immunosuppressive therapy (such as high-dose steroids defined as ≥ 10mg prednisone or equivalent per day) within 4 weeks prior to the 1st scheduled dose of study treatment with the exception of dermocorticoids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Pierre PETERLIN, 0240083271, pierre.peterlin@chu-nantes.fr
About this study
Official title: Multicentric Phase 1 Study With Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine or CPX-351) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)
To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine or CPX-351 in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis
- Being tested
- Darzalex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarzalexDrug
DARZALEX® = Daratumumab. Solution for injection, 1800 mg/15 mL, single vial. Sub-cutaneous administration.
- Dose level 1 : 1800 mg Day 1
- Dose level 2 : 1800 mg Day 1 and 8 (+/- 2 days)
- Dose level 3 : 1800 mg à Day 1, 8 (+/- 2 days) and D15 (+/- 2 days)
| Study group | Role | What they receive |
|---|---|---|
| Darzalex | Experimental | DARZALEX®
Dose level 1 : 1800 mg Day 1 Dose level 2 : 1800 mg Day 1 and 8 (+/- 2 days) Dose level 3 : 1800 mg à Day 1, 8 (+/- 2 days) and D15 (+/- 2 days) Receives: Drug: Darzalex |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose at which no toxic effect is observed, by determination of the LDT (Toxic Limit Dose). A TLD is defined by the occurrence of grade ≥ 3 daratumumab related toxicity that is not reversible after 7 days (except for haematological toxicity) or the absence of emergence from aplasia at D45 of induction (in the absence of treatment failure). Toxicity is assessed according to NCI-CTCAE version 5 criteria. The search for DLT is continued until D45 of induction.
Measured: DAY 45
Secondary outcomes (8)
response to the induction treatment
calculation of the rate of complete remission (CR) with negative residual disease (CR MRD-), CR, CR with incomplete haematological recovery (CRi), MLFS (morphological leukemia free state), partial response (PR) or treatment failure according to the 2022 NLE definition between D30 and D45.
Measured: DAY 45
Assessment of myelotoxicity
Neutrophil recovery time (>1.0 × 109/L) from D1 - Recovery time of platelets (>100 × 109/L) from D1
Measured: Day 1
Overall survival (OS)
time from D1 of induction to date of last contact or death
Measured: 6 months
Event-free survival (EFS)
time from D1 of induction to date of relapse, death or date of last
Measured: 6 months
Relapse incidence
Measured: 6 months
Flow cytometry (FCM) investigation of myeloid-derived suppressor cells
Measured: Day 45
Comparison of MDSC values in CMF
Measured: Day 45
research on the level of CD38 expression on blasts
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start6 Feb 2025
- Primary completion6 Aug 2028 (estimated)
- Study completion6 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Adverse Risk Acute Myeloblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Continual Reassessment Method for MTD
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MATHILDE HUNAULT, Principal investigator, University Hospital, AngersMARC BERNARD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749276
- Sponsor's protocol ID
- RC22_0372
- Acronym
- DARALAM
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Phase 1 Study With Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine or CPX-351) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)
- ClinicalTrials.gov ID
- NCT05749276
- Acronym / sponsor ID
- DARALAM / RC22_0372
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 6 Aug 2028 (estimated)
- Study completion
- 6 Aug 2028 (estimated)
- First posted
- 1 Mar 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.
To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine or CPX-351 in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Continual Reassessment Method for MTD
| Arm | Type | Receives |
|---|---|---|
| Darzalex | Experimental | Drug: DarzalexDARZALEX® Dose level 1 : 1800 mg Day 1 Dose level 2 : 1800 mg Day 1 and 8 (+/- 2 days) Dose level 3 : 1800 mg à Day 1, 8 (+/- 2 days) and D15 (+/- 2 days) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 60 ans
- Poor prognosis AML defined according to the following criteria:1. For first-line AML:intermediate or unfavorable risk according to ELN 2022 2.for Relapsed AML:regardless of the ELN risk group
- ECOG <= 2
- Patient eligible for intensive chemotherapy
- Who provide their written informed consent
Key exclusion criteria (14 listed)
- Patients with FLT3 ITD or TKD mutation
- Patients with tuberculosis
- Patients with documented active infection with COVID 19
- Patients with hereditary fructose intolerance (HFI)
- Uncontrolled infection
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 |
|---|---|---|
| DarzalexDARZALEX® = Daratumumab. Solution for injection, 1800 mg/15 mL, single vial. Sub-cutaneous administration. * Dose level 1 : 1800 mg Day 1 * Dose level 2 : 1800 mg Day 1 and 8 (+/- 2 days) * Dose level 3 : 1800 mg à Day 1, 8 (+/- 2 days) and D15 (+/- 2 days) | Drug | Darzalex |
Primary outcome
DLT
Time frame: DAY 45
Dose at which no toxic effect is observed, by determination of the LDT (Toxic Limit Dose). A TLD is defined by the occurrence of grade ≥ 3 daratumumab related toxicity that is not reversible after 7 days (except for haematological toxicity) or the absence of emergence from aplasia at D45 of induction (in the absence of treatment failure). Toxicity is assessed according to NCI-CTCAE version 5 criteria. The search for DLT is continued until D45 of induction.
8 secondary outcomes
response to the induction treatment
Time frame: DAY 45
Assessment of myelotoxicity
Time frame: Day 1
Overall survival (OS)
Time frame: 6 months
Event-free survival (EFS)
Time frame: 6 months
Relapse incidence
Time frame: 6 months
Flow cytometry (FCM) investigation of myeloid-derived suppressor cells
Time frame: Day 45
Comparison of MDSC values in CMF
Time frame: Day 45
research on the level of CD38 expression on blasts
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
MATHILDE HUNAULT principal investigator
University Hospital, Angers
MARC BERNARD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Darzalex in people with Adult Patients With Adverse Risk Acute Myeloblastic Leukemia, run by Nantes University Hospital 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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 25 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PIERRE PETERLIN (02 40 08 32 71, Pierre.PETERLIN@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: DAY 45). 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 25 Jun 2026.