A Phase II study evaluating efficacy of KTE-X19 CAR-T cell therapy in Relapsed or Refractory Mantle-Cell Lymphoma achieving a partial response during Ibrutinib salvage therapy

Conditions

Relapsed or Refractory Mantle-Cell Lymphoma

Brief summary

CR rate at 90 days after KTE-X19 infusion in patients in PR after Ibrutinib single agent therapy

Detailed description

12 months PFS, 12 months OS, 24 and 36 months PFS, 24 and 36 months OS, DOR, CR rate at 180 days and 365 days after KTE-X19 infusion, NRM, Rates of CRS and ICANS [graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Grading System], including description of the use of tocilizumab, corticosteroids and other treatments for their management, rate of HLH/MAS and other AEs [graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5)], Rate of MRD negativity for those patients with bone marrow (BM) involvement at study entry, ORR/CR rates at 90 days after KTE-X19 infusion for patients with poor clinical and biological risk factors including POD24, high Ki-67 levels, blastoid/pleomorphic morphology and TP53 mutations/deletions

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGIMBRUVICA 140 mg hard capsules

DRUGFLUDARABINE

DRUGTecartus 0.4 - 2 × 10e8 cells dispersion for infusion

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CR rate at 90 days after KTE-X19 infusion in patients in PR after Ibrutinib single agent therapy	—

Secondary

Measure	Time frame
12 months PFS, 12 months OS, 24 and 36 months PFS, 24 and 36 months OS, DOR, CR rate at 180 days and 365 days after KTE-X19 infusion, NRM, Rates of CRS and ICANS [graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Grading System], including description of the use of tocilizumab, corticosteroids and other treatments for their management, rate of HLH/MAS and other AEs [graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5)], Rate of MRD negativity for those patients with bone marrow (BM) involvement at study entry, ORR/CR rates at 90 days after KTE-X19 infusion for patients with poor clinical and biological risk factors including POD24, high Ki-67 levels, blastoid/pleomorphic morphology and TP53 mutations/deletions	—

Measure

Time frame

12 months PFS, 12 months OS, 24 and 36 months PFS, 24 and 36 months OS, DOR, CR rate at 180 days and 365 days after KTE-X19 infusion, NRM, Rates of CRS and ICANS [graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Grading System], including description of the use of tocilizumab, corticosteroids and other treatments for their management, rate of HLH/MAS and other AEs [graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5)], Rate of MRD negativity for those patients with bone marrow (BM) involvement at study entry, ORR/CR rates at 90 days after KTE-X19 infusion for patients with poor clinical and biological risk factors including POD24, high Ki-67 levels, blastoid/pleomorphic morphology and TP53 mutations/deletions

—

Countries

Italy

Outcome results

None listed