Clinical trial NCT00006226: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: B-cell Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 5 years
measure: Progression-free survival
timeFrame: Up to 5 years
measure: Time to progression
timeFrame: Up to 5 years
measure: Duration of response
timeFrame: Up to 5 years
measure: Maximum grade of each type of toxicity
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: North Central Cancer Treatment Group
state: Minnesota
Study officials:
affiliation: North Central Cancer Treatment Group
name: Neil Kay
role: PRINCIPAL_INVESTIGATOR
References: