This trial is active, not recruiting.

Condition b-cell chronic lymphocytic leukemia
Treatments rituximab, glucocorticoid
Phase phase 2
Target CD20
Sponsor Prof. Dr. Med. Laimonas Griskevicius
Start date October 2011
End date June 2016
Trial size 30 participants
Trial identifier NCT01576588, LT-CLL-2s


The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4). Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
rituximab MabThera
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.

Primary Outcomes

Overall response rate
time frame: 3 months +/- 2 weeks after the last treatment cycle.

Secondary Outcomes

Progression Free Survival and Overall Survival.
time frame: Approximately 21 month.
time frame: 6 months.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The diagnosis of CD20 positive chronic B lymphocytic leukemia (BCLL) confirmed by biopsy or flow-cytometry. - Previously treated patients with stage Rai I-IV and progressive disease (according to IWCLL 2008 guidelines). Active B-CLL is defined by at least one of the following: At least one of the disease related symptoms: - Constitutional symptoms: - Weight loss >10% within the previous 6 months; - Fatigue (e.g., WHO performance status >/=2); - Fever >/=38C >/=2 weeks without evidence of infection; - Night sweats for more than 1 month without evidence of infection. - Evidence of progressive marrow failure as manifested by development of, or worsening of, anemia and/or thrombocytopenia - Autoimmune hemolysis and/or thrombocytopenia poorly responsive to corticosteroid therapy. - Massive (i.e., >/=6 cm bellow left costal margin) or progressive or symptomatic splenomegaly. - Massive lymphadenopathy or conglomerates (i.e., >/=10 cm in largest diameter) or progressive or symptomatic lymphadenopathy. - Progressive lymphocytosis with an increase >50% over a 2-month period or an anticipated doubling time of less than 6 months. In patients with initial blood lymphocyte counts of less than 30x10^9/L LDT should not be used as a single parameter to define treatment indication. Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy. - Either of the following: - 18 years of age or older with impaired performance status (CIRS > 6) and /or - 65 years of age or older with any performance status. - Signed informed consent form. Exclusion Criteria: - Intolerance to exogenous protein or known severe reaction to the administration of Rituximab. - Active infection. - Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1. - TBC or fungal infection within the past 6 months even if adequately controlled by treatment. - Severe organ deficiency preventing the participation in the study. - Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1. - Active peptic ulcer. - Inadequately controlled diabetes mellitus. - Suspected or confirmed B-CLL CNS disease. - Known to be HIV positive. - Difficult to control, uncooperative patients. - Allergic disorders in need of chronic glucocorticoid therapy. - Other oncological diseases requiring active treatment (except hormonal therapy). - Pregnancy and breastfeeding. - Patients of reproductive potential who are not using effective methods of contraception.

Additional Information

Official title Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia
Principal investigator Laimonas Griskevicius, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Vilnius University.