Hematopoietic insufficiency with non-hemolysis-induced Hb 10% weight loss in the last 6 months, persistent or recurrent FUO >38°C, night sweats. MedDRA version: 7 Level: LLT Classification code 10008956
Conditions
Interventions
Trade Name: Ribomustin
Product Name: Ribomustin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Bendamustin
CAS Number: 16506-27-7
Other descriptive name: Bendamustin hydro
Sponsors
ribosepharm GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Treatment-naïve, legally competent adult patients = 75 years of age capable of following study instructions. Patient has given written informed consent (Appendix I). WHO Performance Status 0-2 (Appendix III). Life expectancy = 3 months. Contraception for at least 6 months after therapy Confirmed chronic B-cell lymphocytic leukemia (Coexpression of CD5, CD23 and either CD19 or CD20 or both). Symptomatic Binet stage B or Binet stage C of the disease requiring treatment acc. to the criteria defined by the NCIWG1996. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatment with other cytotoxic drugs. Participation in another clinical trial within 4 weeks prior to or during this study. Mental disorders, drug or alcohol dependence, or any other disorder suggesting compliance problems or limited ability to co-operate in the study. History of a second malignancy (except cured basal cell carcinoma or cured cervical cancer). Manifest immune hemolysis that can be treated with glucocorticoids alone. Manifest immune thrombocytopenia that can be treated with glucocorticoids alone. Richter's syndrome or transformation to PLL. Hepatic dysfunction: bilirubin > 2.0 mg/dL and/or transaminases > 3x ULN. Renal dysfunction (creatinine clearance < 30 mL/min, calculated). Any of the following concomitant diseases: - Overt heart failure; - Cardiomyopathy; - Myocardial infarction within the last six months; - Severe, uncontrollable diabetes mellitus; - Severe, uncontrollable hypertension; - Active infection that requires systemic antibiotic therapy; - Uncontrollable infection; - Clinically manifest cerebral dysfunction. Known HIV infection. Major surgery within 30 days before the start of the trial. Pregnancy, lactation. Hypersensitivity to any of the study drugs. Women of childbearing potential without adequate contraception (e.g. abstinence, oral contraceptives, intrauterine devices, barrier method [diaphragm or condom], plus spermicide).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: overall remission rate (CR/PR) progression free survival;Secondary Objective: time to progression duration of remission overall survival infection rate quality of life side effects (toxicities);Primary end point(s): The primary endpoints of this Phase III study are the overall remission rate (CR+PR) and progression-free survival in chemo-naïve Binet stage B/C B-CLL patients requiring therapy. | — |
Countries
Austria, Italy
Outcome results
None listed