Status:
COMPLETED
Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as IGVH unmutated and ...
Detailed Description
Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young (age ≤65 years) patients with CLL. However, IGVH unmutated patients and patients with disrupted TP53 show an ...
Eligibility Criteria
Inclusion
- Patients older than18 years and 65 years or less.
- Diagnosis of CLL meeting the IWCLL 2008 criteria.
- Total CIRS \<6, creatinine clearance \>30 ml/min \[Cockcroft-Gault\]) and ECOG performance status of 0-1.
- No prior treatment.
- Umutated IGVH and/or disrupted TP53.
- Active disease meeting at least 1 of the following the IWCLL 2008 criteria for treatment requirement.
- Adequate bone marrow function without transfusion \<2 weeks of screening as follows: absolute neutrophil count (ANC) ≥1.0 x 109/L (growth factors administration is allowed); platelets ≥30 x 109/L. If thrombocytopenia due to BM involvement, platelets should be ≥ 30 x 109/L; hemoglobin value ≥8.0 g/dl.
- Adequate renal and hepatic function per local reference laboratory reference ranges
- Female patients of childbearing potential and non-sterile male patients must practice at least one of method of birth control with partner(s) beginning with initial treatment administration and continuing to 12 months after the last dose of Rituximab.
- Male patients must agree to refrain from sperm donation, from initial treatment administration until 12 months after the last dose of Rituximab.
- A signed informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
Exclusion
- Any significant concurrent, uncontrolled medical condition or organ system dysfunction and/or laboratory abnormality or psychiatric disease, which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk or prevent the subject from signing the informed consent form.
- Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia).
- History of other malignancies Pregnant or lactating females.
- Inadequate renal function: CrCl \<30 mL/min.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- Subject is known to be positive for HIV.
- Evidence of other clinically significant uncontrolled condition(s)
- Prior or concomitant fruits and/or specific drugs.
Key Trial Info
Start Date :
October 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03455517
Start Date
October 31 2018
End Date
May 11 2023
Last Update
November 24 2023
Active Locations (31)
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1
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
2
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, Italy
3
Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
Asti, Italy
4
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy