Clinical trial · Interventional
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)
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)
NCT05749276CI-TRIAL-00115832DARALAMrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Patients With Adverse Risk Acute Myeloblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darzalex | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Darzalex
- description
- 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)
- interventionNames
- Drug: Darzalex
Primary outcomes (1)
- measure
- DLT
- timeFrame
- DAY 45
- description
- 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.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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%. Exclusion Criteria: * 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+ * 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
References
Publications (0)
Data not yet available
No reference posted for this study.