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

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Etoposide; Fludarabine; Hydroxyurea; Idarubicin; Methotrexate; Mitoxantrone; Montelukast; Pegaspargase; Vincristine

Criteria

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 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 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 x109/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 order to decrease tumor burden (the study 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 x109/L at the time of screening visit.

• Participants who have been exposed to anti-CD38 therapies within 6 months prior to Day-1.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.