Status:
COMPLETED
Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Grupo Cooperativo de Hemopatías Malignas
Conditions:
B-Cell Chronic Lymphocytic Leukemia
B-Cell Chronic Lymphocytic Leukemia in Relapse (Diagnosis)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
Detailed Description
The international recommendations indicate that the first line of treatment for patients \<65 years old and with no significant comorbidities (fit patients) the known regime of FCR with recommendation...
Eligibility Criteria
Inclusion
- Patients diagnosed with B cell chronic lymphocytic leukemia according to 2017 WHO criteria by immunophenotype/immunohistochemistry with active disease according to the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and do not present TP53 mutation and/or del(17)p. (Cohort 1).
- Patients diagnosed with relapsed/refractory chronic lymphocytic leukemia that have previously received at least one line of treatment that does not include the drugs in the study scheme. (Cohort 2).
- Functional stage of 0 - 2 measured by the Eastern Cooperative Oncology Group (ECOG) scale.
- Creatinine depuration ≥ 30 ml/min measured in a 24-hour urine recollection or utilizing the CKD-EPI formula.
- Proper liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN in patients with Gilbert syndrome, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN.
- Capacity and willingness to provide a written informed consent.
Exclusion
- T cell lymphocytic leukemia diagnosis.
- TP53 mutation and/or del(17)p presence.
- Non-controlled systematic active infection (viral, bacterial and/or fungic).
- Patients with known infection by human immunodeficiency virus (HIV).
- Active infection by hepatitis B (defined as the presence of detectable HBV's DNA, HBe antigen or HBs antigen). Patients with serological evidence of previous vaccination (HBsAg negative, anti-HBs positive antibodies, anti-HBc negative antibodies) are eligible. The patients that are HBsAg negative/ anti-Hbs positive antibodies but anti-HBc positive antibodies are eligible, if the HBV DNA is negative, and the HBV-DNA PCR is realized every 12 months after the last cycle of treatment.
- Active infection by hepatitis C, defined by the ribonucleic acid (RNA) of hepatitis C is detectable in plasma by polymerase chain reaction (PCR).
- Significant cardiovascular diseases such as uncontrolled or symptomatic arrhythmias, congestive heart failure or acute myocardial infarction within 2 months prior to screening, or any class 3 or 4 heart disease according to the functional classification of the NYHA.
- Diagnosis of previous malignancies for 2 years, with exception of patients with basal or squamous cell carcinoma or "in situ" carcinoma of cervix or breast.
- Requiring therapy with inhibitors or potent inducers of CYP3A4 and CYP3A5 inhibitors.
- Anticoagulant therapy with acenocoumarol or warfarin.
- History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to screening.
- History of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies.
- Pregnant or lactating women.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03755947
Start Date
December 1 2018
End Date
February 1 2021
Last Update
February 2 2021
Active Locations (1)
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1
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, State of Mexico, Mexico, 52763