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

Sponsor
Canadian Cancer Trials Group
Study ID
NCT04161248
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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
  • Rituximab Injection — DRUG
    375 mg/m2 - Day 1, cycle 1.
  • Rituximab SC — DRUG
    1400 mg fixed dose - Day 1, cycle 2 and 3
  • Gemcitabine — DRUG
    1000 mg/m2 - Day 1 to day 8
  • Dexamethasone — DRUG
    40 mg daily - Day 1 to day 4
  • Cisplatin — DRUG
    75mg/m2 - Day 1
  • Glofitamab — DRUG
    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
  • Tafasitamab — DRUG
    Cycle 1: Tafasitamab (12 mg/kg IV day -1, 8, 15) Cycles 2 and 3: Tafasitamab (12 mg/kg IV day 1, 8, 15)

Study Details

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.

Key Dates

Start date
Sep 2, 2020
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + R-GDP
  • Experimental: Glofitamab + R-GDP
  • Experimental: Tafasitamab + R-GDP

Primary Outcome Measure

Establish maximum tolerated dose of new combination therapy [ Time Frame: 4 years ]

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