Trial Details 16 Total Sites

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

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

status

Recruiting

enrollment

96

score

25

start date

2019-08-06

last updated

2021-12-08

biomarkers

N/A

Dallas, Texas
facility
Investigational Site Number :8400002
1 facility
Recruiting
Seattle, Washington
facility
Investigational Site Number :8400003
1 facility
Recruiting
Nashville, Tennessee
facility
Investigational Site Number :8400001
1 facility
Recruiting
Cincinnati, Ohio
facility
Investigational Site Number :8400004
1 facility
Recruiting
Seoul, South Korea
facility
Investigational Site Number :4100001
facility
Investigational Site Number :4100004
+2 more facilities
4 facilities
Recruiting
São Paulo, Brazil
facility
Investigational Site Number :0760004
facility
Investigational Site Number :0760001
2 facilities
Recruiting
Curitiba, Brazil
facility
Investigational Site Number :0760013
facility
Investigational Site Number :0760006
2 facilities
Recruiting
Montréal, Canada
facility
Investigational Site Number :1240003
1 facility
Recruiting
Porto Alegre, Brazil
facility
Investigational Site Number :0760007
1 facility
Recruiting
Ribeirão Preto, Brazil
facility
Investigational Site Number :0760009
1 facility
Recruiting
Vancouver, Canada
facility
Investigational Site Number :1240001
1 facility
Recruiting
Monza, Italy
facility
Investigational Site Number :3800001
1 facility
Recruiting