Cohort 1: Cytologic R/R T-cell ALL 

(≥5% blasts in bone marrow) 

Patients will receive a standard pre-phase with Dexamethasone and 

Cyclophosphamide which is not part of the trial 

All patients will receive two cycles of induction therapy with standard 

chemotherapy, Bortezomib and Isatuximab. 

Induction I: 

Isatuximab, Bortezomib, Dexamethasone, Vincristine, Daunorubicine, PEGAsparaginase 

Induction II: 

Isatuximab, Cyclophosphamide, Cytarabine, Mercatopurine, i.th. Methotrexate 

Isatuximab maintenance may be administered in patients with CR until SCT, 

progression/relapse, unacceptable toxicity, physicians’ decision to change 

treatment or withdrawal of consent. 

Hematologic response and MRD response will be evaluated in bone marrow after 

induction 1 and 2, before SCT or every two months and at end of treatment. For 

further efficacy follow-up bone marrow evaluations are recommended 2-3 

monthly in Standard of Care. 

Most patients are candidates for SCT. The expected realization rate of SCT in 

patients with hematologic CR after R/R ALL is 60-70%. SCT is not part of the 

protocol, but details like conditioning regimen, mortality and outcome will be 

documented. 

In the remaining patients, e.g. patients with contraindications for SCT like higher 

age can receive an Isatuximab maintenance treatment as described for cohort 2 

together with a conventional maintenance with mercaptopurine/methotrexate 

and optional Vincristine/ Dexamethasone pulses. Isatuximab maintenance will end 

at 6 months. 

Strict recommendations will be given as part of the GMALL standards for 

subsequent SCT including conditioning regimens and GvHD prophylaxis.