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

Not Applicable

Recruiting

• Conditions: C910; C920; -C920 Acute myeloblastic leukaemia [AML]-C910 Acute lymphoblastic leukaemia [ALL]; Acute lymphoblastic leukaemia [ALL]; Acute myeloblastic leukaemia [AML]

• Registration Number: PER-023-20
• Lead Sponsor: Sanofi Aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-18
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

INCLUSION CRITERIA
Participants are eligible to be included in the study only if all of the following criteria apply:
01. Age
Participant must be 28 days to less than 18 years of age at the time of the signing of the
informed consent. Participants under 2 years of age can only be enrolled after the dose
reassessment is completed on the first 20 participants who are 2 to less than 18 years of
age (see Section 4.3 and Section 9.5).
02. Type of participant and disease characteristics
Participants must have a confirmed diagnosis of relapsed ALL of T- or B-cell origin
including lymphoblastic lymphoma (LBL, or relapsed AML (excluding M3 type: acute
promyelocytic leukemia) including participants with history of myelodysplasia (MDS).

03. Sex
A) Male participants: A male participant with a female partner of childbearing potential must
agree to use contraception as detailed in Appendix 4 (Section 10.4) of this protocol during
the treatment period and for at least 6 months after the last dose of isatuximab, or
12 months after the last dose of cyclophosphamide and refrain from donating sperm during
this period.
B) Female participants: A female participant is eligible to participate if she is not pregnant
(see Appendix 4 [Section 10.4]), not breastfeeding, and at least one of the following
conditions applies:
04. Informed Consent
The participant who has reached legal age of majority as defined by local regulation or the
parent(s)/legal guardian(s) must provide signed informed consent prior to any study-related
procedures being performed. If the participant is legally a minor per local regulations,
assent shall be obtained from the participant, if applicable.

Exclusion Criteria

EXCLUSION CRITERIA
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
01. Evidence of ongoing infection or seropositivity for human immunodeficiency virus (HIV),
or active hepatitis B (defined as either positive hepatitis B surface [HBs] antigen or
positive hepatitis B viral deoxyribonucleic acid [DNA] test above the lower limit of
detection of the assay), or hepatitis C infection. Presence of positive hepatitis B core (HBc)
antibody in the presence of a negative HBs antigen test or a negative hepatitis B viral DNA
test in serum indicates a prior infection without currently active hepatitis or carrier status
and is not an exclusion criterion. Human immunodeficiency virus, hepatitis B, and
hepatitis C virus serology testing to be performed and collected in database only in
countries where requested by local regulations.
E 02. Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ
carcinoma, unless they are successfully treated with curative intent for more than 3 years
before entering the study.
E 03. Cardiomyopathy New York Heart Association Grade 3 or 4.
E 04. History of thrombophilic disease, allergic to asparaginase for participants with ALL, or
prior intolerance (ie, serious thrombosis, pancreatitis, or hemorrhagic events).
E 05. Eastern Cooperative Oncology Group (ECOG) performance status >2 or Lansky score <70
(see Section 10.6.2 and Section 10.6.3).
E 06. Total bilirubin >2.5 × upper limit of normal (ULN) unless the participant has
Gilbert’s syndrome or elevation related to acute leukemia.
E 07. Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase >5 × ULN,
unless considered due to the disease.
E 08. Serum creatinine >2 × ULN and/or estimated glomerular filtration rate (eGFR)
<30 mL/min/1.73 m2 (by revised Schwartz equation, Section 10.6.4).
E 09. Any serious active disease or comorbid condition that, in the opinion of the Investigator,
may interfere with the safety of the study intervention or the compliance with the study
protocol.
Prior/concomitant therapy
E 10. Participants must have been off prior treatment with immunotherapy/investigational agents
and chemotherapy for >2 weeks and must have recovered from acute toxicity (ie, to
Grade 1 or less except alopecia or peripheral neuropathy Grade ≤2 without pain) before the
first study intervention administration. The study treatment may start earlier if necessitated
by the participant´s medical condition (eg, rapidly progressive disease) following
discussion with the Sponsor.
E 11. 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 intervention administration.
Prior/concurrent clinical study experience
E 12. Intolerance or contraindication to treatment with mAb or any other drug part of the study
intervention.
Other exclusion criteria are described in protocol section 5.2

Study & Design

• Study Type: Interventional
• Study Design: Not specified