Haematological malignancy MedDRA version: 19.0 Level: PT Classification code 10042987 Term: T-cell type acute leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10036543 Term: Precursor T-lymphoblastic lymphoma/leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: isatuximab
Product Code: SAR650984
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: isatuximab
Other descriptive name: SAR650984
Concentration unit: mg/ml
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy. -Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration. -Patients must have been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue). -No more than 3 prior salvage therapies. Are the trial subjects under 18? yes Number of subjects for this age range: 7 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration. - Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration. - Clinical evidence of active central nervous system (CNS) leukemia. - T-ALL with testicular involvement alone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of isatuximab.;Secondary Objective: -To evaluate the safety profile of isatuximab. -To evaluate the duration of response (DOR). -To evaluate progression free survival (PFS) and overall survival (OS). -To evaluate the pharmacokinetics (PK) of isatuximab in patients with T-ALL or T-LBL. -To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL. -To assess minimal residual disease (MRD) and correlate it with clinical outcome.;Primary end point(s): Objective response rate;Timepoint(s) of evaluation of this end point: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Duration of response - time 2/ Progression free survival - time 3/ Overall survival - time;Timepoint(s) of evaluation of this end point: 1-2-3 : 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) | — |
Countries
Finland, France, Hungary, Italy, Lithuania, Russian Federation, United States
Contacts
Public ContactClinical Study Unit
UAB Sanofi-Aventis Lietuva
Outcome results
None listed