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Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia

NCT03755947 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-02-02

No results posted yet for this study

Summary

Background: Chronic Lymphocytic Leukemia (CLL) is the most common leukemia in the occidental countries. Until now, it is considered a chronic disease without a cure. The development of new molecular therapies have showed that the cure may be an option. This protocol propose a triple sequential therapy with three direct therapies for the leukemic cell: an inhibitor of Bruton´s tyrosine kinase (ibrutinib), a second generation monoclonal antibody versus CD20 (obinutuzumab) and a BCL-2 inhibitor (venetoclax) as treatment of first or second line in CLL.

Objective: Negativize the minimal residual disease and by this way obtain longer survivals (overall survival and relapse free survival).

Design: This is a multicenter, longitudinal, experimental, open, non-randomized and non-comparable study coordinated by the "Grupo Cooperativo de Hemopatías Malignas" situated on Hospital Angeles Lomas in Huixquilucan, México. The study, is a phase II clinical study that will employ three target therapy drugs in sequencing phases. It will start with a BTK inhibitor as induction, later an anti-CD20 will be used for consolidation and it will end with a BH3 analog as maintenance for one year. The primary outcome is the negativization of minimal residual disease.

Conditions

  • B-Cell Chronic Lymphocytic Leukemia
  • B-Cell Chronic Lymphocytic Leukemia in Relapse (Diagnosis)

Interventions

DRUG

Ibrutinib

Ibrutinib Oral Capsule \[Imbruvica\] Tablets 120 mg. Oral. 420mg/day, day 1 to 28, every 28 days. 3 cycles.

DRUG

Obinutuzumab

Obinutuzumab Injection. Intravenous Solution \[Gazyva\] Parenteral. 1000 mg, day 1 of every cycle, every 28 days. 6 cycles.

DRUG

Venetoclax

Venetoclax Oral Tablets \[Venclexta\] Tablets 100 mg. Oral. 400 mg/day. Day 1 to 28, every 28 days. 12 cycles.

Sponsors & Collaborators

  • Grupo Cooperativo de Hemopatías Malignas

    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
2018-12-01
Primary Completion
2020-12-31
Completion
2021-02-01

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

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 NCT03755947 on ClinicalTrials.gov