KILT - GLA 2021-6

To evaluate the median modified progression-free survival (mPFS) of Lacutamab in patients treated with Gemcitabine-oxaliplatine at relapse followed by a Lacutamab maintenance, in R/R patients with KIR3DL2 positive PTCL-NOS, PTCL-TFH (including AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), ALCL, ATL, HSTL, EATL, MEITL, NKT, ANKL, PCGD-TCL, SPTCL.

The primary endpoint is the modified PFS rate, calculated as time from randomization until one of the following event occurs, whichever comes first: a) Disease progression (PD) b) Institution of any additional unplanned anti-tumor treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) c) Relapse after achievement of CR/CRu or d) Death due to any cause. PD 
and relapse will be evaluated according to Lugano criteria (2014) by CT-scan. 

Patients aged over 18 years old with KIR3DL2+ Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype (e.g angioimmunoblastic T-cell lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), anaplastic large-cell lymphoma (ALCL), HTLV-1 associated T-cell lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL) and other rare PTCL, as enteropathyassociated T-cell  lymphoma (EATL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), NK/T-cell lymphoma (NKT), aggressive NK cell leukemia (ANKL), primary cutaneous gamma/delta positive T-cell lymphoma (PCGD-TCL), subcutaneous panniculitis-like T-cell lymphoma (SPTCL)

Experimental: Lacutamab

• Lacutamab 750 mg/IV + GEmOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase Lacutamab 750 mg/IV for a maximum of 20 additional cycles of 4 weeks during the maintenance phase

• Interventions:

  • Drug: Lacutamab
  • Drug: Gemcitabine
  • Drug: Oxaliplatine
• Active Comparator: Standard of care
  • GemOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase
  • Interventions:

    • Drug: Gemcitabine
    • Drug: Oxaliplatine