UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
Data Collection
Hematologic Diseases+1
+ Leukemia
+ Neoplasms
Treatment Study
Summary
Study start date: August 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location