Completed

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

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What is being tested

Data Collection

Who is being recruted

Hematologic Diseases
+1

+ Leukemia
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1998
See protocol details

Summary

Principal SponsorUniversity of Arkansas
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1998Actual 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.

Official TitleUARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia 
NCT00083694
Principal SponsorUniversity of Arkansas
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hematologic Diseases
Leukemia
Neoplasms
Neoplasms by Histologic Type
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
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
Suspended
University of Arkansas for Medical Sciences/MIRTLittle Rock, United StatesSee the location
CompletedOne Study Center
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