UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
18 Years
N/A
Both
Leukemia
Trial Information
UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
Principal Investigator
Barthel Barlogie, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UAMS
Authority:
United States: Food and Drug Administration
Study ID:
UARK 98-032
NCT ID:
NCT00083694
Start Date:
August 1998
Completion Date:
May 2005
Related Keywords:
- Leukemia
- Leukemia
- Thalidomide
- relapsed
- Leukemia
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences/MIRT | Little Rock, Arkansas 72205 |
