Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006226
First received: September 11, 2000
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used.

  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used.

  • Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used.

  • Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Maximum grade of each type of toxicity [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    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:

PRIMARY OBJECTIVES:

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.

OUTLINE:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006226

Locations
United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Neil Kay North Central Cancer Treatment Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006226     History of Changes
Other Study ID Numbers: NCI-2012-01852, NCI-2012-01852, NCCTG-N9986, CDR0000068148, N9986, N9986, U10CA025224
Study First Received: September 11, 2000
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014