NCT03755947

Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia

Completed Phase 2 Last updated 2 February 2021

What this trial tests

Phase 2 trial testing Ibrutinib in B-Cell Chronic Lymphocytic Leukemia in 3 participants. Completed in 1 February 2021.

Timeline

1 December 2018

Primary endpoint
31 December 2020

1 February 2021

Quick facts

Lead sponsor	Grupo Cooperativo de Hemopatías Malignas
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 December 2018
Primary completion	31 December 2020
Estimated completion	1 February 2021
Sites	1 location across Mexico

Drugs / interventions tested

• Ibrutinib (ibrutinib) — full drug profile →
• Obinutuzumab — full drug profile →
• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• B-Cell Chronic Lymphocytic Leukemia — all drugs for B-Cell Chronic Lymphocytic Leukemia →
• B-Cell Chronic Lymphocytic Leukemia in Relapse (Diagnosis) — all drugs for B-Cell Chronic Lymphocytic Leukemia in Relapse (Diagnosis) →

Sponsor

Grupo Cooperativo de Hemopatías Malignas — full company profile →

Who can join

18 and older, any sex, with B-Cell Chronic Lymphocytic Leukemia or B-Cell Chronic Lymphocytic Leukemia in Relapse (Diagnosis). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. BH3-mimetics: recent developments in cancer therapy.
   Townsend PA, Kozhevnikova MV, Cexus ONF, Zamyatnin AA, et al · · 2021 · cited 70× · PMID 34753495 · DOI 10.1186/s13046-021-02157-5
2. Combination strategies to overcome resistance to the BCL2 inhibitor venetoclax in hematologic malignancies.
   Yue X, Chen Q, He J. · · 2020 · cited 51× · PMID 33292251 · DOI 10.1186/s12935-020-01614-z
3. Restoring Apoptosis with BH3 Mimetics in Mature B-Cell Malignancies.
   Jullien M, Gomez-Bougie P, Chiron D, Touzeau C. · · 2020 · cited 13× · PMID 32183335 · DOI 10.3390/cells9030717
4. Clinical application of obinutuzumab for treating chronic lymphocytic leukemia.
   Luan C, Chen B. · · 2019 · cited 13× · PMID 31692500 · DOI 10.2147/dddt.s212500
5. Emerging treatment options for patients with p53-pathway-deficient CLL.
   Aitken MJL, Lee HJ, Post SM. · · 2019 · cited 12× · PMID 31839919 · DOI 10.1177/2040620719891356
6. Approaches for relapsed CLL after chemotherapy-free frontline regimens.
   Roeker LE, Mato AR. · · 2020 · cited 8× · PMID 33275712 · DOI 10.1182/hematology.2020000168