Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

University of Arkansas

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: Thalidomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00083694

UARK 98-032

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)