Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia

Sponsor
Grupo Cooperativo de Hemopatías Malignas
Study ID
NCT03755947
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib Oral Capsule \[Imbruvica\] Tablets 120 mg. Oral. 420mg/day, day 1 to 28, every 28 days. 3 cycles.
  • Obinutuzumab — DRUG
    Obinutuzumab Injection. Intravenous Solution \[Gazyva\] Parenteral. 1000 mg, day 1 of every cycle, every 28 days. 6 cycles.
  • Venetoclax — DRUG
    Venetoclax Oral Tablets \[Venclexta\] Tablets 100 mg. Oral. 400 mg/day. Day 1 to 28, every 28 days. 12 cycles.

Study Details

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.

Key Dates

Start date
Dec 1, 2018
Status verified
Feb 2021
Primary completion
Dec 31, 2020
Completion
Feb 1, 2021

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IGV
    Cytoreduction 3 cycles (I) Ibrutinib, \[Imbruvica, Janssen\] Induction 6 cycles (G) Obinutuzumab, \[Gazyva, Roche\] Consolidation 12 cycles (V) Venetoclax, \[Venclexta, Abbvie\].

Primary Outcome Measure

Best response obtained [ Time Frame: Two months after finishing the triple sequencing therapy ]

Related Studies