Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Refractory Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006226
• Other study ID #: NCI-2012-01852
• Secondary ID: NCI-2012-01852NC
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: October 7, 2013
• Start date: September 2000

Study information

• Verified date: October 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• thalidomide
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	North Central Cancer Treatment Group	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart	Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.	Up to 5 years	No
Secondary	Overall survival	The Kaplan-Meier method will be used.	Up to 5 years	No
Secondary	Progression-free survival	The Kaplan-Meier method will be used.	Up to 5 years	No
Secondary	Time to progression	The Kaplan-Meier method will be used.	Up to 5 years	No
Secondary	Duration of response		Up to 5 years	No
Secondary	Maximum grade of each type of toxicity	Frequency tables will be reviewed.	Up to 5 years	Yes