MedTrace Logo

A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations

NCT03226301 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2022-08-02

No results posted yet for this study

Summary

The aim of the current trial is to evaluate if combination treatment with venetoclax + ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients randomized to stopping treatment after 15 induction cycles.

Conditions

  • Chronic Lymphocytic Leukemia in Relapse
  • Chronic Lymphocytic Leukemia in Remission

Interventions

DRUG

Ibrutinib + Venetoclax 15 cycles

Cycle 1 + 2: 420 mg ibrutinib, day 1-28 \| Cycle 3: 420 mg ibrutinib, day 1-28 \| 20 mg venetoclax, day 1-7 \| 50 mg venetoclax, day 8-14 \| 100 mg venetoclax, day 15-21 \| 200 mg venetoclax, day 22-28 \| Cycle 4-15: 420 mg ibrutinib, day 1-28 + 400mg venetoclax, day 1-28

DRUG

Ibrutinib until progression/relapse

420mg ibrutinib daily until progression/relapse

DRUG

Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles

Cycle 1: 420 mg ibrutinib \| 20 mg venetoclax, day 1-7 \| 50 mg venetoclax, day 8-14 \| 100 mg venetoclax, day 15-21 \| 200 mg venetoclax, day 22-28 \| cycles 2-12: 420 mg ibrutinib, day 1-28 + 400 mg venetoclax, day 1-28

Sponsors & Collaborators

  • Nordic CLL Study Group

    collaborator UNKNOWN

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-23
Primary Completion
2021-06-30
Completion
2026-06-21

Countries

  • Belgium
  • Denmark
  • Finland
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

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 NCT03226301 on ClinicalTrials.gov