MedTrace Logo

Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients

NCT02345863 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-05-08

No results posted yet for this study

Summary

A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib and GA101 maintenance in CLL patients.

Conditions

  • Chronic Lymphocytic Leucemia

Interventions

DRUG

Bendamustine

Debulking: 2 cycles of Bendamustine (70 mg/m² iv) will be administered before induction unless a contraindication is existing or it is not clinically indicated.

DRUG

GA101

Induction GA101 iv infusion: Cycle 1: Day 1 100 mg Day 1 (or 2) 900 mg Day 8 1000 mg Day 15 1000 mg Cycle 2-6: Day 1 1000 mg Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued. GA101: Cycle 1-8 Day 1 1000 mg

DRUG

Ibrutinib

Ibrutinib will be administered as a daily oral dosage of 420 mg starting on cycle 2 day 1. Cycle 2-6: Day 1 420 mg daily Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued. Ibrutinib: Cycle 1-8 420 mg daily

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Julia von Tresckow, Dr. med. · German CLL Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-16
Primary Completion
2016-08-22
Completion
2019-03-29

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 NCT02345863 on ClinicalTrials.gov