NCT05888493 - A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma | Biotech Hunter

Enrollment

108

Participants

Timeline

Start Date

October 2, 2023

Primary Completion Date

July 25, 2028

Study Completion Date

January 18, 2031

Conditions

Follicular Lymphoma (FL)

Interventions

BIOLOGICAL

Tisagenlecleucel

Tisagenlecleucel is a solution for infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells taken intravenously (i.v.).

DRUG

Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles.

Lenalidomide 20 mg daily on days 1-21 for up to 12 cycles Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2-5

DRUG

Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cycles

Rituximab 375 mg/m2 i.v. on day 1 Cyclophosphamide 750 mg/m2 i.v. day 1 Doxorubicin 50 mg/m2 i.v. day 1 Vincristine 1.4 mg/2 (capped at 2 mg) i.v. day 1 Prednisone or prednisolone 40 mg/m2 PO days 1-5

DRUG

Lymphodepleting chemotherapy

"Fludarabine (25 mg/m\^2 intravenously \[i.v.\] daily for 3 doses) OR Cyclophosphamide (250 mg/m\^2 i.v. daily for 3 doses starting with the first dose of fludarabine).~OR Bendamustine 90 mg/m\^2 i.v. daily for 2 days (If there was previous grade IV hemorrhagic cystitis with cyclophosphamide, or the participant demonstrated resistance to a previous cyclophosphamide-containing regimen)"

OTHER

Corticosteroids and/or Radiation (Bridging therapy)

Corticosteroids and/or Radiation

Trial Locations (36)

2050

RECRUITING

Novartis Investigative Site, Camperdown

3004

RECRUITING

Novartis Investigative Site, Melbourne

3168

RECRUITING

Novartis Investigative Site, Clayton

4020

RECRUITING

Novartis Investigative Site, Linz

5020

RECRUITING

Novartis Investigative Site, Salzburg

6009

RECRUITING

Novartis Investigative Site, Nedlands

10002

RECRUITING

Novartis Investigative Site, Taipei

14004

RECRUITING

Novartis Investigative Site, Córdoba

15706

RECRUITING

Novartis Investigative Site, Santiago de Compostela

28034

RECRUITING

Novartis Investigative Site, Madrid

30120

RECRUITING

Novartis Investigative Site, El Palmar

37007

RECRUITING

Novartis Investigative Site, Salamanca

37212

RECRUITING

VA Tennessee Valley Healthcare System, Nashville

39008

RECRUITING

Novartis Investigative Site, Santander

45220

RECRUITING

TRIHEALTH Good Samarithan Hospital, Cincinnati

83301

RECRUITING

Novartis Investigative Site, Kaohsiung City

83310

RECRUITING

Novartis Investigative Site, Bratislava

119074

RECRUITING

Novartis Investigative Site, Singapore

407219

RECRUITING

Novartis Investigative Site, Taichung

M5G 2M9

RECRUITING

Novartis Investigative Site, Toronto

H1T 2M4

RECRUITING

Novartis Investigative Site, Montreal

708 52

RECRUITING

Novartis Investigative Site, Ostrava

H-1097

RECRUITING

Novartis Investigative Site, Budapest

60-355

RECRUITING

Novartis Investigative Site, Poznan

44-101

RECRUITING

Novartis Investigative Site, Gliwice

80-952

RECRUITING

Novartis Investigative Site, Gdansk

93 513

RECRUITING

Novartis Investigative Site, Lodz

022328

RECRUITING

Novartis Investigative Site, Bucharest