Treated high-risk chronic B lymphocytic leukemia. MedDRA version: 9.1 Level: LLT Classification code 10003947 Term: B-Lymphocytic, CLL (Kiel Classification) recurrent MedDRA version: 9.1 Level: LLT Classification code 10003948 Term: B-Lymphocytic, CLL (Kiel Classification) refractory
Conditions
Interventions
Trade Name: Solu-Medrol
Product Name: Methylprednisolone
Product Code: MP
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Methylprednisolone
CAS Number: 83-43-2
Concentratio
Sponsors
Vilnius University Hospital Santariskiu Clinics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be considered for registration into this study, subjects must satisfy all of the following inclusion criteria: 1. The diagnosis of CD20 positive chronic B lymphocytic leukemia (B-CLL) confirmed by biopsy or flow-cytometry. 2. Relapsed or progressive disease after at least 1 prior chemotherapy. 3. Stage Rai I-IV and progressive disease (according to NCI criteria). 4. High-risk B-CLL biologically or clinically. 5. Older than 18 years. 6. Signed informed consent form. 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: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening: 1. Intolerance to exogenous protein or known severe reaction to the administration of Rituximab. 2. Active infection. 3. Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1. 4. TBC or fungal infection within the past 6 months even if adequately controlled by treatment. 5. Severe organ deficiency preventing the participation in the study. 6. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1. 7. Severe liver disease (total bilirubine or transaminases > 3 times ULN), except caused by the B-CLL. 8. Active peptic ulcer. 9. Inadequately controlled diabetes mellitus. 10. Suspected or confirmed B-CLL CNS disease. 11. Known to be HIV positive. 12. Difficult to control, uncooperative patients. 13. Allergic disorders in need of chronic glucocorticoid therapy. 14. Other oncological diseases requiring active treatment (except hormonal therapy). 15. Pregnancy and breastfeeding. 16. Patients of reproductive potential who are not using effective methods of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.;Secondary Objective: To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.;Primary end point(s): To determine efficiency and safety of the treatment in the investigative population. | — |
Countries
Lithuania
Outcome results
None listed