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A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia

Phase 2
18 Years
Not Enrolling
B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia

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Trial Information

A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia


I. To determine whether thalidomide can induce objective responses in relapsed B-CLL

II. To determine the toxicity of thalidomide in this patient population. III. To document if
alterations in vascular growth factors and/or bone marrow angiogenesis patterns correlate
with thalidomide related clinical responses.


Patients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to
1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

Inclusion Criteria:

- Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of
mature CD5+, CD19+, CD23+, and B cells

- Relapsed after prior treatment for CLL

- Active disease with 1 or more of the following characteristics:

- At least 10% weight loss within the past 6 months

- Fever greater than 100.5 degrees F for at least 2 weeks without evidence of

- Night sweats without evidence of infection

- Evidence of progressive marrow failure with anemia (hemoglobin less than 11
g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm^3) (i.e., any
stage III or IV disease)

- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid

- Massive or progressive splenomegaly (i.e., greater than 6 cm below the left
costal margin or more than 50% increase over 2 months)

- Progressive lymphadenopathy (i.e., more than 50% increase over 2 months)

- Progressive lymphocytosis (not due to corticosteroids) with an increase of more
than 50% over a 2-month period or an anticipated doubling time of less than 6

- Marked hypogammaglobulinemia or the development of a monoclonal protein in the
absence of any of the above criteria for active disease are not considered
evidence of active disease

- Measurable disease

- Absolute lymphocyte count greater than 5,000/mm^3

- No bulky lymph node disease greater than 10 cm in at least 1 dimension except

- Performance status - ECOG 0-2

- Absolute neutrophil count at least 500/mm^3

- Platelet count at least 20,000/mm^3 (in absence of sargramostim [GM-CSF])

- Hemoglobin at least 8 g/dL

- Bilirubin no greater than 2.5 times upper limit of normal (ULN)

- AST no greater than 2.5 times ULN

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No other active malignancy

- No peripheral neuropathy (sensory) grade 2 or greater

- No active infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 1 highly effective method of contraception AND 1 additional
effective method of contraception for at least 4 weeks before, during, and for 4
weeks after study completion

- No prior allogeneic bone marrow transplantation

- At least 10 days since prior filgrastim (G-CSF) or GM-CSF

- No more than 3 prior chemotherapy regimens

- At least 30 days since prior chemotherapy

- No concurrent corticosteroids except for adrenal insufficiency

Type of Study:


Study Design:

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

Outcome Measure:

Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart

Outcome Description:

Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Neil Kay

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2000

Completion Date:

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



North Central Cancer Treatment Group Rochester, Minnesota  55905