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Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL

NCT02758665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-01-17

No results posted yet for this study

Summary

A prospective, open-label, multicentre phase-II trial of ibrutinib plus venetoclax plus obinutuzumab in physically fit (CIRS ≤ 6 \& normal creatinine clearance) and unfit (CIRS \> 6 \& creatinine clearance ≥ 50 ml/min) patients with previously untreated chronic lymphocytic leukemia (CLL) with TP53 deletion (17p-) and/or mutation

Conditions

  • Leukemia, Lymphocytic, Chronic

Interventions

DRUG

ibrutinib

DRUG

obinutuzumab

DRUG

venetoclax

Sponsors & Collaborators

  • German CLL Study Group

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • AbbVie

    collaborator INDUSTRY

  • University of Ulm

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2022-01-31
Completion
2022-03-31

Countries

  • Germany

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 NCT02758665 on ClinicalTrials.gov