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Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: September 11, 2000
Last updated: October 7, 2013
Last verified: October 2013
Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor.

Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Drug: thalidomide
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart [ Time Frame: Up to 5 years ]
    Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ]
    The Kaplan-Meier method will be used.

  • Progression-free survival [ Time Frame: Up to 5 years ]
    The Kaplan-Meier method will be used.

  • Time to progression [ Time Frame: Up to 5 years ]
    The Kaplan-Meier method will be used.

  • Duration of response [ Time Frame: Up to 5 years ]
  • Maximum grade of each type of toxicity [ Time Frame: Up to 5 years ]
    Frequency tables will be reviewed.

Estimated Enrollment: 41
Study Start Date: September 2000
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (thalidomide)
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.
Drug: thalidomide
Given PO
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 infection
    • 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 therapy
    • 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 months
    • 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 splenomegaly
  • 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
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Please refer to this study by its identifier: NCT00006226

United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Neil Kay North Central Cancer Treatment Group
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00006226     History of Changes
Other Study ID Numbers: NCI-2012-01852
NCI-2012-01852 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N9986 ( Other Identifier: North Central Cancer Treatment Group )
N9986 ( Other Identifier: CTEP )
U10CA025224 ( US NIH Grant/Contract Award Number )
Study First Received: September 11, 2000
Last Updated: October 7, 2013

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 25, 2017