Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Study on Investigational Medication for Pediatric Leukemia, a Cancer Affecting Blood and Bone Marrow

Not Recruiting
28 days - 17 years
All
Phase 2
67 participants needed

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
  • Age: 28 days - 17 years
  • 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.

Updated on 16 May 2024. Study ID: NCT03860844

This study investigates the effects of an investigational medication in combination with standard chemotherapy for children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). Leukemia is a type of cancer that affects blood and bone marrow. The study focuses on understanding how well the investigational medication works against leukemia when used with other treatments.

Participants will receive the investigational medication along with standard chemotherapy. Safety and tolerability will be monitored, and researchers will check how the body processes the medication. The study will also evaluate the response rates and survival outcomes. Participants will be closely monitored for any reactions to the treatment.

  • Who can participate: Children aged 28 days to less than 18 years with relapsed or refractory ALL or AML and a confirmed diagnosis can participate. They should have a white blood cell count below 20 x10^9/L before starting the investigational medication.
  • Study details: Participants will receive an investigational medication along with standard chemotherapy, with safety assessments and monitoring of how the body processes the medication. A placebo is not used in this study.