search
Back to results

Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Primary Purpose

B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thalidomide
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Central Cancer Treatment Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (thalidomide)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival
The Kaplan-Meier method will be used.
Progression-free survival
The Kaplan-Meier method will be used.
Time to progression
The Kaplan-Meier method will be used.
Duration of response
Maximum grade of each type of toxicity
Frequency tables will be reviewed.

Full Information

First Posted
September 11, 2000
Last Updated
October 7, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00006226
Brief Title
Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Official Title
A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (thalidomide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart
Description
Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The Kaplan-Meier method will be used.
Time Frame
Up to 5 years
Title
Progression-free survival
Description
The Kaplan-Meier method will be used.
Time Frame
Up to 5 years
Title
Time to progression
Description
The Kaplan-Meier method will be used.
Time Frame
Up to 5 years
Title
Duration of response
Time Frame
Up to 5 years
Title
Maximum grade of each type of toxicity
Description
Frequency tables will be reviewed.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Kay
Organizational Affiliation
North Central Cancer Treatment Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Central Cancer Treatment Group
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

We'll reach out to this number within 24 hrs