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NCT00083694 Clinical Trial

Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00083694
Other study ID # UARK 98-032
Secondary ID
Status Completed
Phase Phase 2
First received May 27, 2004
Last updated July 1, 2010
Start date August 1998
Est. completion date May 2005

Study information
Verified date July 2010
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 25
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Thalidomide

Locations
Country Name City State
United States University of Arkansas for Medical Sciences/MIRT Little Rock Arkansas

Sponsors (2)
Lead Sponsor Collaborator
University of Arkansas Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
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