Spots Global Cancer Trial Database for Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Official Title: 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
Study ID: NCT03860844
Interventions
Study Description
Brief Summary: Primary Objective: 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
Detailed Description: The study included: * a screening period of up to (up to 3 weeks prior to the first study treatment administration); * a study treatment period \[Day 1 to Day 57 for Acute Lymphoblastic Leukemia (ALL); Day 1 to Day 22 for Acute Myeloid Leukemia (AML)\]; * the period of aplasia followed by a recovery period; * an end of treatment (EOT) visit \[within 30 days after hematological recovery; * a follow-up period (until final analysis cut off date).
Keywords
Eligibility
Minimum Age: 28 Days
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute-Site Number:8400001, Nashville, Tennessee, United States
Children's Medical Center of Dallas-Site Number:8400002, Dallas, Texas, United States
Investigational Site Number :0320002, Caba, Buenos Aires, Argentina
Investigational Site Number :0320006, Capital Federal, Buenos Aires, Argentina
Investigational Site Number :0320005, Buenos Aires, , Argentina
Investigational Site Number :0320004, Buenos Aires, , Argentina
Investigational Site Number :0760013, Curitiba, Paraná, Brazil
Investigational Site Number :0760006, Curitiba, Paraná, Brazil
Investigational Site Number :0760007, Porto Alegre, Rio Grande Do Sul, Brazil
Investigational Site Number :0760010, Jau, São Paulo, Brazil
Investigational Site Number :0760009, Ribeirao Preto, São Paulo, Brazil
Investigational Site Number :0760001, Sao Paulo, São Paulo, Brazil
Investigational Site Number :0760004, Sao Paulo, São Paulo, Brazil
Investigational Site Number :2080001, Copenhagen, , Denmark
Investigational Site Number :2500002, Lille, , France
Investigational Site Number :2500003, Lyon, , France
Investigational Site Number :2500001, PARIS Cedex 12, , France
Investigational Site Number :2500004, PARIS Cedex 19, , France
Investigational Site Number :2760005, Erlangen, , Germany
Investigational Site Number :2760003, Hamburg, , Germany
Investigational Site Number :2760006, Münster, , Germany
Investigational Site Number :3000001, Athens, , Greece
Investigational Site Number :3480002, Budapest, , Hungary
Investigational Site Number :3800002, Genova, Liguria, Italy
Investigational Site Number :3800001, Monza, Lombardia, Italy
Investigational Site Number :3800003, Torino, Piemonte, Italy
Investigational Site Number :3800005, Verona, Veneto, Italy
Investigational Site Number :4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4100004, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number :4840001, Monterrey, Nuevo León, Mexico
Investigational Site Number :4840005, Col. Rancho Menchaca, Querétaro, Mexico
Investigational Site Number :5280001, Utrecht, , Netherlands
Investigational Site Number :5780001, Bergen, , Norway
Investigational Site Number :5780002, Oslo, , Norway
Investigational Site Number :6040001, Arequipa, , Peru
Investigational Site Number :6040002, Lima, , Peru
Investigational Site Number :6200002, Coimbra, , Portugal
Investigational Site Number :6200001, Lisboa, , Portugal
Investigational Site Number :6200003, Porto, , Portugal
Investigational Site Number :7520001, Göteborg, , Sweden
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
