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

NCT04161248 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-12

No results posted yet for this study

Summary

The purpose of this study is to find the highest dose of a new drug, in combination with standard drugs, which can be tolerated without causing very severe side effects. The study treatment is new agents in combination with R-GDP or an equivalent regimen.

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)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • AbbVie

    collaborator INDUSTRY

  • Incyte Corporation

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Sarit Assouline · The Jewish General Hospital, Montreal QC, Canada

  • Diego Villa · BCCA - Vancouver Cancer Centre, BC, Canada

  • Tara Baetz · Cancer Centre of Southeastern Ontario at Kingston, ON, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04161248 on ClinicalTrials.gov