Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 2, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

July 31, 2026

Conditions
Lymphoma, B-Cell
Interventions
DRUG

Venetoclax

"Dose Level -1: Venetoclax 200 mg/day days 4-8 cycle 1, days 1-5 cycle 2 and 3, + R-GDP~Dose Level 1: Venetoclax 200 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP~Dose Level 2: Venetoclax 400 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP~Dose Level 3: Venetoclax 800 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP"

DRUG

Rituximab Injection

375 mg/m2 - Day 1, cycle 1.

DRUG

Rituximab SC

1400 mg fixed dose - Day 1, cycle 2 and 3

DRUG

Gemcitabine

1000 mg/m2 - Day 1 to day 8

DRUG

Dexamethasone

40 mg daily - Day 1 to day 4

DRUG

Cisplatin

75mg/m2 - Day 1

DRUG

Glofitamab

Cycle 1: Glofitamab 2.5 mg (day 8) and 10 mg (day 15) + R-GDP Cycle 2: Glofitamab 30 mg (day 8) + R-GDP Cycle 3: Glofitamab 30 mg (day 8) + R-GDP

DRUG

Tafasitamab

Cycle 1: Tafasitamab (12 mg/kg IV day -1, 8, 15) Cycles 2 and 3: Tafasitamab (12 mg/kg IV day 1, 8, 15)

Trial Locations (4)

V5Z 4E6

RECRUITING

BCCA - Vancouver, Vancouver

K7L 2V7

RECRUITING

Kingston Health Sciences Centre, Kingston

M5G 2M9

RECRUITING

University Health Network, Toronto

H3T 1E2

RECRUITING

The Jewish General Hospital, Montreal

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

collaborator

AbbVie

INDUSTRY

collaborator

Incyte Corporation

INDUSTRY

lead

Canadian Cancer Trials Group

NETWORK