Rituximab in Pretreated Elderly or Unfit B-CLL Patients
This trial is active, not recruiting.
|Condition||b-cell chronic lymphocytic leukemia|
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Overall response rate
time frame: 3 months +/- 2 weeks after the last treatment cycle.
Progression Free Survival and Overall Survival.
time frame: Approximately 21 month.
time frame: 6 months.
Male or female participants at least 18 years old.
- 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.
- 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.
|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.|
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