Leukemia
Conditions
Keywords
Leukemia, Thalidomide, relapsed
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.
Interventions
DRUGThalidomide
Sponsors
Celgene Corporation
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of Thalidomide in patients with leukemia. | — |
Countries
United States
Outcome results
None listed