Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Investigational Medication with Chemotherapy for Pediatric Leukemia
Study Overview
Primary Objective:
Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)
Secondary Objectives:
- Safety and tolerability assessments
- Assessment of infusion reactions (IRs)
- Pharmacokinetics (PK) of isatuximab
- Minimal residual disease
- Overall response rate
- Overall survival
- Event free survival
- Duration of response
- Relationship between clinical effects and CD38 receptor density and occupancy
Study Details
The study included:
- a screening period of up to (up to 3 weeks prior to the first study treatment administration);
- a study treatment period [Day 1 to Day 57 for Acute Lymphoblastic Leukemia (ALL); Day 1 to Day 22 for Acute Myeloid Leukemia (AML)];
- the period of aplasia followed by a recovery period;
- an end of treatment (EOT) visit [within 30 days after hematological recovery;
- a follow-up period (until final analysis cut off date).
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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Age: 28 days - 17 years
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Gender: All
Inclusion criteria:
- Participant 28 days to less than 18 years of age, at the time of signing the informed consent.
- Participants must have had a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.
- Participants must have been previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse were eligible regardless of the remission duration.
- Participants who had no more than 1 prior salvage therapy.
- White Blood Cell (WBC) counts below 20 x10^9/L on Day 1 before isatuximab administration
Exclusion criteria:
- Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol.
- Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for >2 weeks and must have recovered from acute toxicity before the first study treatment administration. Exceptions were participants who needed to receive cytoreductive chemotherapy in order to decrease tumor burden (the study treatment may have started earlier if necessitated by the patient's medical condition (eg, rapidly progressive disease) following discussion with the Sponsor).
- Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration.
- Participants with LBL with bone marrow blasts <5%.
- Participants with Burkitt-type ALL.
- Acute leukemia with testicular or central nerve system involvement alone.
- Participants who had developed therapy related acute leukemia.
- Live vaccine(s) within 30 days prior to the first IMP administration or plans to receive such vaccines during the study until 90 days after the last IMP administration.
- Participants with white blood cell count > 50 x10^9/L at the time of screening visit.
- Participants who had been exposed to anti-CD38 therapies within 6 months prior to Day-1.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study investigates the use of an investigational medication in combination with standard chemotherapy for children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML). The study aims to understand the anti-leukemic effects of this combination in young patients.
Participants will undergo various procedures, including safety assessments, evaluations of infusion reactions, and monitoring of the investigational medication's behavior in the body (pharmacokinetics). The study will also measure the response to treatment, survival rates, and the relationship between the medication's effects and specific cell markers. Participants will follow a treatment schedule that includes a screening period, treatment period, and follow-up visits.
- Who can participate: Children aged 28 days to less than 18 years with a confirmed diagnosis of relapsed ALL or AML can participate. They must have been previously treated and have specific white blood cell counts. Participants should not have serious active diseases or recent stem cell transplants.
- Study details: Participants will receive the investigational medication alongside standard chemotherapy. They will be monitored for safety and treatment response. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine is not used in this study.
- Study timelines: The study will last up to 57 days for ALL and up to 22 days for AML.
