LeukemiaPhase 2NCT00083694
Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
A Phase 2 study testing Thalidomide in people with Leukemia, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Thalidomide
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, 72205
About this study
Official title: UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.
Read the detailed 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.
- Conditions
- Leukemia
- Being tested
- Thalidomide
- Keywords
- Leukemia, Thalidomide, relapsed
- Medical subject headings
- Leukemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2004 (estimated)
- Study startAug 1998
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Barthel Barlogie, M.D., Ph.D., Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083694
- Sponsor's protocol ID
- UARK 98-032
- Status last verified
- Jul 2010
- First submitted
- 27 May 2004
- Last updated
- 2 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
- ClinicalTrials.gov ID
- NCT00083694
- Acronym / sponsor ID
- UARK 98-032
- Conditions
- Leukemia
- Keywords
- Leukemia, Thalidomide, relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Aug 1998
- Study completion
- May 2005
- First posted
- 31 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide | Drug | – |
Primary outcome
To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2010.
- Myeloma Institute for Research \& Therapy websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barthel Barlogie, M.D., Ph.D. principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Leukemia, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy and safety of Thalidomide in patients with leukemia.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2010.