Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration.
Participants must had 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.
You may not be if
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.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
