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Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia

Phase 2
18 Years
Open (Enrolling)
B-Cell Chronic Lymphocytic Leukemia

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Trial Information

Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia

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.

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

- Massive (i.e., >/=6 cm bellow left costal margin) or progressive or symptomatic

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

ORR is defined as the proportion of patients achieving CR, CR with MRD negativity (Complete Molecular Remission), nPR and PR

Outcome Time Frame:

3 months +/- 2 weeks after the last treatment cycle.

Safety Issue:


Principal Investigator

Laimonas Griskevicius, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santariskiu Clinics


Lithuania: State Medicine Control Agency - Ministry of Health

Study ID:




Start Date:

October 2011

Completion Date:

October 2016

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Chronic lymphocytic leukemia, relapsed, elderly or unfit patients, methylprednisolone, rituximab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, B-Cell