Acute Myeloid Leukemia Clinical Trial
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
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
Full 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).
Eligibility 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.
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There are 43 Locations for this study
Nashville Tennessee, 37203, United States
Dallas Texas, 75235, United States
Caba Buenos Aires, C1181, Argentina
Capital Federal Buenos Aires, C1425, Argentina
Buenos Aires , 1118, Argentina
Buenos Aires , C1245, Argentina
Curitiba Paraná, 80250, Brazil
Curitiba Paraná, 81520, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Jau São Paulo, 17210, Brazil
Ribeirao Preto São Paulo, 14051, Brazil
Sao Paulo São Paulo, 04039, Brazil
Sao Paulo São Paulo, 08270, Brazil
Copenhagen , 2100, Denmark
Bordeaux , 33000, France
Lille , 59000, France
Lyon , 69008, France
PARIS Cedex 12 , 75571, France
PARIS Cedex 19 , 75935, France
Erlangen , 91054, Germany
Essen , 45147, Germany
Hamburg , 20246, Germany
Münster , 48149, Germany
Athens , 115 2, Greece
Budapest , 1094, Hungary
Roma Lazio, 00165, Italy
Genova Liguria, 16147, Italy
Monza Lombardia, 20900, Italy
Torino Piemonte, 10126, Italy
Verona Veneto, 37126, Italy
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Seoul Seoul-teukbyeolsi, 03722, Korea, Republic of
Seoul Seoul-teukbyeolsi, 06351, Korea, Republic of
Seoul Seoul-teukbyeolsi, 06351, Korea, Republic of
Monterrey Nuevo León, 64460, Mexico
Col. Rancho Menchaca Querétaro, 76140, Mexico
Utrecht , 3584 , Netherlands
Bergen , 5021, Norway
Oslo , 0342, Norway
Arequipa , , Peru
Lima , 34, Peru
Coimbra , 3000-, Portugal
Lisboa , 1099-, Portugal
Porto , 4200-, Portugal
Göteborg , 416 8, Sweden
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