Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
Phase 2
Completed
- Conditions
- Leukemia
- Registration Number
- NCT00083694
- Lead Sponsor
- University of Arkansas
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.
- Detailed Description
Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of complete remission then as long as it is beneficial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS.
- Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed
- Serum creatinine < or = 2.5mg/dL
- Serum bilirubin< or = 2.5mg/dL
- Negative pregnancy test
- Age 18 years or older
- Performance status < or = 3
Exclusion Criteria
- Pregnant or lactating women
- Concurrent treatment with cytotoxic chemotherapy, or radiation
- History of seizures, neurotoxicity, or active CNS disease
- Serious infections not controlled by antibiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arkansas for Medical Sciences/MIRT
🇺🇸Little Rock, Arkansas, United States