Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients with High Risk Chronic B Lymphocytic Leukemia - High-dose Methylprednisolone and Rituximab in High Risk B-C

• Conditions: Treated high-risk chronic B lymphocytic leukemia.; MedDRA version: 9.1Level: LLTClassification code 10003947Term: B-Lymphocytic, CLL (Kiel Classification) recurrent; MedDRA version: 9.1Level: LLTClassification code 10003948Term: B-Lymphocytic, CLL (Kiel Classification) refractory

• Registration Number: EUCTR2007-001818-16-LT
• Lead Sponsor: Vilnius University Hospital Santariskiu Clinics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.