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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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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/MIRTLittle Rock, Arkansas  72205