Combination of Obinutuzumab and Venetoclax in Relapsed or Refractory DLBCL

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study ID
NCT02987400
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    3 cycles followed by 9 cycles consolidation if not transplant eligible
  • Obinutuzumab — DRUG
    3 cycles followed by 9 cycles consolidation if not transplant eligible

Study Details

The purpose of this study is to evaluate the clinical activity and tolerability of a combination of obinutuzumab plus venetoclax in patients with relapsed or refractory diffuse large B-cell lymphoma.

Key Dates

Start date
Jan 4, 2017
Status verified
Feb 2022
Primary completion
Oct 19, 2021
Completion
Oct 19, 2021

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Obinutuzumab is given in a 21 day cycle intravenously starting at 1000 mg on day 1, 8 and 15 in cycle 1 and on day 1 of each following cycle Venetoclax is given orally at a dose of 800mg daily from day 1 of the first cycle.

Primary Outcome Measure

Clinical activity and tolerability [ Time Frame: After 3 cycles of treatment (9 weeks) ]

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