LLPC Associated studies

Early treatment intensification in patients with high risk Mantle Cell Lymphoma using CAR-T-cell treatment after an abbreviated

induction therapy with Rituximab and Ibrutinib and 6 months Ibrutinib maintenance (Arm A) as compared to standard of care induction and maintenance (Arm B)

previously untreated MCL, high risk. At least one High risk MCL feature, defined as 
I. MIPI-c high intermediate (HI) or high (H) risk (i.e. high-risk MIPI irrespective of Ki-67
or intermediate risk MIPI and Ki-67>=30% (Ki-67 based on local pathology)
and/or
II. TP53 deletion and /or mutation and/or TP53 overexpression by immunohistochemistry (> 50% of lymphoma cells), sequencing (mutations and deletions) or FISH

KT-US-484-0136: An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma.

2 cohorts:
Cohort 1: R/R DLBCL of Folliculair lymfoom gr 3b after 2 lines systemic therapy or after 1 line systemic therapy in transplant-ineligible patients. Cohort for CART-exposed patients is temporary closed
Cohort 2: Folliculair lymfoom gr 1-3a and marginale zone lymfoom after 2 of more lines systemic therapy (including an anti CD20 antibody)  - open 

A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton’s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies

R/R CLL/SLL with CNS involvement

In- en exclusiecriteria
Advertentie text (approved by EC)