Rituximab in Pretreated Elderly or Unfit B-CLL Patients
The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.
B-Cell Chronic Lymphocytic Leukemia
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia|
- Overall response rate [ Time Frame: 3 months +/- 2 weeks after the last treatment cycle. ] [ Designated as safety issue: No ]ORR is defined as the proportion of patients achieving CR, CR with MRD negativity (Complete Molecular Remission), nPR and PR
- Progression Free and Overall Survival. [ Time Frame: Approximately 21 month. ] [ Designated as safety issue: No ]PFS will be defined as the interval from entry into the study to disease progression or death. OS will be defined as the interval from entry into the study to death.
- Safety [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]Adverse events NCI CTCAE, version 4.0.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Patient Population: Pretreated patients with symptomatic B-CLL 18-64 years of age with poor performance status or >/=65 years of age with any performance status.
Treatment: Up-to 4 cycles of glucocorticoid (Methylprednisolone or Dexamethasone) and Rituximab every 21 day.
Study Duration: The study period for each subject is expected to be 21 months. Subjects will receive up-to 4 cycles of IV infusion of Rituximab and Glucocorticoid. Maximum duration of treatment is expected to be 6 months. Subjects will complete scheduled visits not later than Study Month 21, thereafter they will enter into the long-term follow-up period. Subjects will be followed every 3 months for disease progression, initiation of subsequent leukemia treatment or survival.
|Contact: Laimonas Griskevicius, MDfirstname.lastname@example.org|
|Contact: Tadas Zvirblisemail@example.com|
|Vilnius University Hospital Santariskiu Clinics||Recruiting|
|Vilnius, Lithuania, 08661|
|Contact: Laimonas Griskevicius, MD +37052365029 firstname.lastname@example.org|
|Contact: Tadas Zvirblis +37060422106 email@example.com|
|Sub-Investigator: Regina Pileckyte, MD|
|Sub-Investigator: Indre Klimiene, MD|
|Principal Investigator:||Laimonas Griskevicius, MD||Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santariskiu Clinics|