Chronic lymphocytic leukemia MedDRA version: 16.1 Level: LLT Classification code 10008977 Term: Chronic lymphocytic leukemia recurrent System Organ Class: 100000004864
Conditions
Sponsors
Roche Farma, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Have documented CD20+ B-CLL according to NCI criteria (see Appendix 2) 3. Active disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment: a) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (Hgb 10% within the previous 6 months prior to Screening ii. Fever higher than 38.0ºC for 2 or more weeks prior to Screening without evidence of infection iii. Night sweats for more than 1 month prior to Screening without evidence of infection. 4. Refractory CLL (i.e. treatment failure or progression within 6 months of treatment) or relapse CLL (i.e. patient who met criteria for CR or PR, but progressed beyond 6 months post-treatment). 5. At least 1 prior purine analogue or bendamustine containing therapy 6.Creatinine clearance =30ml/min or both 7.Hemoglobin > 9 g/dL; absolute neutrophil count (ANC) = 1.5 x 109/L and platelets (Plt) = 75 x 109/L unless cytopenia is caused by the underlying disease, i.e. no evidence of additional bone marrow dysfunction (e.g. myelodysplastic syndrome [MDS]) 8.Life expectancy >6-8 months 9.Able and willing to provide written informed consent and to comply with the study protocol procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 43 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: 1.Prior Alogenic Bone Marrow Transplant 2.= 3 previous lines of chemotherapy and/or immunotherapy for the CLL. 3.Previous obinutuzumab-containing regimen. 4.Refractory CLL to bendamustine treatment (i.e. treatment failure or progression within 6 months of bendamustine-containing regimen). 5.Transformation of CLL to aggressive NHL (Richter’s transformation) 6.Active haemolytic anaemia 7.Inadequate liver function: NCICTC Grade 3 liver function tests (AST, ALT >5 x ULN for >2 weeks; Bilirubin >3 x ULN) unless due to underlying disease. 8.History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated but not with curative intent will be excluded, unless the malignancy has been in remission without treatment for = 2 years prior to enrolment. Patients with a history of adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent are eligible. 9.Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm). 10.Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis. 11.Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1, unless administered for indications other than lymphoma at a dose equivalent to = 30 mg/day prednisone 12.Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 4 weeks prior to the start of Cycle 1. 13.Patients with known infection with Human immunodeficiency virus (HIV) or Human T Cell Leukemia Virus 1 (HTLV-1). 14.Positive hepatitis serology: a)Hepatitis B (HBV): Patients with positive serology for Hepatitis B defined as positivity for Hepatitis B surface antigen (HBsAg) or anti Hepatitis B core antibody (anti-HBc). Patients positive for anti-HBc may be included if Hepatitis B viral DNA is not detectable. b)Hepatitis C (HCV): Patients with positive Hepatitis C serology unless HCV (RNA) is confirmed negative. 15.History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 16.Known sensitivity or allergy to murine products. 17.Known hypersensitivity to any of the study drugs 18.Women who are pregnant or lactating 19.Fertile men or women of childbearing potential unless: (1) surgically sterile or = 2 years after the onset of me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall response rate (ORR) after treatment with obinutuzumab and bendamustine, in patients with refractory or relapsed chronic lymphocytic leukemia (CLL).; Secondary Objective: - To evaluate the best response rate during study treatment and until 6-8 months after end of study treatment, according IWCLL2008 criteria - To evaluate progression free survival (PFS). - To evaluate overall survival (OS) and event free survival (EFS). - To evaluate disease free survival (DFS) among patients with complete response (CRi or CR). - To evaluate duration of response (DR) among patients with complete (CRi or CR) or partial response. - To evaluate time to re-treatment/new anti-leukemia therapy. - To evaluate remission using multi-parametric flow cytometry. - To evaluate the safety profile of the study treatment. ;Primary end point(s): Overall response rate (ORR) will be calculated. In addition the best response rate (CR/CRi and PR) up to 6-8 months after treatment will also be estimated.; Timepoint(s) of evaluation of this end point: Overall response rate (ORR) [i.e. Complete Response (CR), CR incomplete (CRi) or Partial Response (PR)] at the end of study treatment Best response (CR/CRi and PR) up to 6 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to event endpoints such as progression free survival, event-free survival, disease-free survival, re-treatment/new ant-leukemic therapy, overall survival and duration of response. Safety of the treatment will be evaluated by: adverse events, laboratory tests and vital signs. ; Timepoint(s) of evaluation of this end point: -Time to event : since ciclo 1 until the event. Safety profile of treatment: assessment and monitoring of adverse events during treatment and subsequent observation period of the trial. | — |
Countries
Spain
Contacts
Public ContactMarta Maislan
Roche Farma, S.A.
Outcome results
None listed