Trial | NCT00083694  Report issue

Title

Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    25
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with 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.
Study Started
Aug 31
1998
Study Completion
May 31
2005
Last Update
Jul 02
2010
Estimate

Drug Thalidomide

Criteria 

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
No Results Posted