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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    96
  • sponsor
    Sanofi
Updated on 24 June 2022
remission
fludarabine
cyclophosphamide
lymphoma
hydroxyurea
myelodysplasia
methotrexate
cytarabine
filgrastim
minimal residual disease
daunorubicin
residual tumor
mitoxantrone
idarubicin

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

Description

The study will include a screening period of up to 21 days (Day -21 to -1), a study treatment period [Day 1 to Day 57 for Acute Lymphoblastic Leukemia (ALL); Day 1 to Day 22 for Acute Myeloid Leukemia (AML)], a recovery period (until an end of treatment visit [within 30 days after hematological recovery]) and a follow-up period (until final analysis cut off date).

Details
Condition Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Treatment cyclophosphamide, methotrexate, filgrastim, cytarabine, etoposide, hydroxyurea, Fludarabine, Dexamethasone, Tocilizumab, vincristine, doxorubicin, Mitoxantrone, Idarubicin, Daunorubicin, Montelukast, Isatuximab, Liposomal daunorubicin, PEG Asparaginase, L - Asparginase, L - Asparaginase (Erwinase)
Clinical Study IdentifierNCT03860844
SponsorSanofi
Last Modified on24 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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