This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL). The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Institut Jules Bordet
Anderlecht, Belgium
VZW ZAS
Antwerp, Belgium
A. Z. Sint-Jan
Bruges, Belgium
Cliniques Universitaires de Bruxelles - Hôpital Erasme
Brussels, Belgium
Cliniques universitaires Saint-Luc - Université catholique de Louvain
Brussels, Belgium
Grand Hôpital de Charleroi
median modified progression-free survival (mPFS) - CT-based
time from randomization until one of the following events occurs, whichever comes first: 1. Disease progression (PD) 2. Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) 3. Relapse after achievement of CR 4. Death due to any cause. PD and relapse will be evaluated according to Lugano 2014 criteria (CT-based).
Time frame: 5,5 years.
median modified progression-free survival (mPFS) - PET-based
Time frame: 5,5 years.
Number of Adverse Events
Time frame: 5,5 years.
overall survival (OS)
Time frame: 5,5 years.
complete response rate (CRR) Lugano 2014 criteria (CT-based)
Time frame: 5,5 years.
complete response rate (CRR) Lugano 2014 criteria (PET-based)
Time frame: 5,5 years.
overall response rate (ORR) Lugano 2014 criteria (CT-based)
Time frame: 5,5 years.
overall response rate (ORR) Lugano 2014 criteria (PET-based)
Time frame: 5,5 years.
response rate assessed by Deauville criteria
Time frame: 5,5 years.
duration of response (DOR),
1. Disease progression (PD) 2. Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) 3. Relapse after achievement of CR 4. Death due to any cause
Time frame: 5,5 years.
rate of patients proceeding to allogenic stem cell transplantation
Time frame: 5,5 years.
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 1 month (1 cycle)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 1 month (1 cycle)
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 2 months (2 cycles)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 2 months (2 cycles)
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 3 months (3 cycles)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 3 months (3 cycles)
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 7 months (7 cycles)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 7 months (7 cycles)
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 9 months (9 cycles)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 9 months (9 cycles)
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 15 months (15 cycles)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 15 months (15 cycles)
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 26 months (26 cycles)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 26 months (26 cycles)
Pharmacokinetics of lacutamab with GemOx : Maximal Concentration of lacutamab (Cmax)
Time frame: 29 months (29 cycles)
Pharmacokinetics of lacutamab with GemOx : Trough Concentration of lacutamab (Ctrough)
Time frame: 29 months (29 cycles)
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 1 month (1 cycle)
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 2 months (2 cycles)
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 3 months (3 cycles)
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 7 months (7 cycles)
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 9 months (9 cycles)
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 15 months (15 cycles)
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 26 months
Immunogenicity : concentration of Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
Time frame: 29 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charleroi, Belgium
UZ Antwerpen
Edegem, Belgium
HELORA - Hôpital de La LouvièreSite Jolimont
Haine-Saint-Paul, Belgium
CHU de LIEGE - Domaine Sart Tilman
Liège, Belgium
Clinique CHC MontLégia
Liège, Belgium
...and 54 more locations