Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination with Chemotherapy in Pediatric Patients from 28 Days to Less than 18 Years of Age with Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

- Participant must be 28 days to less than 18 years of age, at the time of
signing the informed consent.
- Participants must have a confirmed diagnosis of relapsed ALL of T or B cell
origin including LBL, or relapsed AML (excluding M3 type: acute promyelocytic
leukemia) including participants with history of myelodysplasia (MDS).
- Participants must be previously treated for their disease and have relapsed
or are refractory to most recent treatment. Participants in first or second
relapse will be eligible regardless of the remission duration.
- Participants with no more than 1 prior salvage therapy.
- WBC counts below 20 x 109/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 are participants who need to receive
cytoreductive chemotherapy in orde to decrease tumor burden. Treatment may
start 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 have 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 x 109/L at the time of the
screening visit.
- Participants who have been exposed to anti-CD38 therapies within 6 months
prior to Day-1.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Complete Response (CR) rate in Acute myeloid leukemia (AML) cohort<br /><br><br /><br>Complete Response (CR) rate in B-cell Acute lymphoblastic leukemia (B-ALL)<br /><br>cohort<br /><br><br /><br>Complete Response (CR) rate in T-cell Acute lymphoblastic leukemia (T-ALL)<br /><br>cohort </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and tolerability assessments: Adverse events<br /><br><br /><br>Assessment of infusion reactions (IR's)<br /><br><br /><br>Pharmacokinetics of isatuximab: Cmax, Ctrough and AUC<br /><br><br /><br>Minimal residual disease in participants achieving CR or CRi.<br /><br><br /><br>Overall response rate<br /><br><br /><br>Overall survival<br /><br><br /><br>Event free survival<br /><br><br /><br>Duration of response<br /><br><br /><br>Change in CD38 receptor density and occupancy</p><br>