AnemiaPhase 2NCT00053001
Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome
A Phase 2 study testing epoetin alfa and thalidomide in people with Anemia and Leukemia, run by Fallon Clinic at 2 sites in United States.
Trial summary
RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve anemia, decrease the need for blood transfusions, and improve the quality of life in patients with myelodysplastic syndrome. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anemia, Leukemia, Myelodysplastic Syndromes
- What is being tested?
- epoetin alfa and thalidomide
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jun 2001to Oct 2007
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndromes
- Newly diagnosed OR
- Prior treatment was unsuccessful, including treatment with chemotherapy
- International prognostic scoring system score no greater than 1.5
- Hemoglobin no greater than 10 g/dL (untransfused) AND/OR
- Received at least 3 units of packed red blood cells for symptomatic anemia within the past 6 weeks
PATIENT CHARACTERISTICS:
Age
- Over 21
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 6 months
Hematopoietic
- See Disease Characteristics
- No prior bleeding disorder
Hepatic
- Bilirubin less than 2 mg/dL
- ALT/AST less than 2 times upper limit of normal
Renal
- Creatinine less than 1.5 mg/dL
Cardiovascular
- No prior clinically significant heart disease
- No uncontrolled hypertension
- No recent thromboembolic disease (e.g., deep vein thrombosis)
- Prior thromboembolic events allowed provided event occurred at least 6 weeks prior to study and patient is on anticoagulants and is clinically stable
Pulmonary
- No unstable pulmonary disease
- No recent pulmonary embolism
- No active pulmonary infection
Neurologic
- No pre-existing peripheral neuropathy greater than grade 2
- No sustained neurologic deficit
- No epilepsy
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods (including 1 highly effective method) of contraception for at least 4 weeks before, during, and for at least 4 weeks after study completion
- No active infection
- No concurrent illness that would obscure toxicity or dangerously alter drug metabolism
- No other serious concurrent medical illness
- No uncontrolled diabetes mellitus
- No other malignant disease (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off therapy for that disease for more than 1 year
- No known hypersensitivity to mammalian cell-derived products or human albumin
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 4-6 weeks since prior therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, 01608
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, 01655
About this study
Official title: A Phase II Study on the Effectiveness of Thalomid (Thalidomide) Combined With Procrit (Erythropoietin) for the Treatment of Anemia in Patients With Low and Intermediate Risk-1 (IPSS Score Less Than or Equal to 1.5) Myelodysplastic Syndromes
RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve anemia, decrease the need for blood transfusions, and improve the quality of life in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa in treating anemia in patients who have myelodysplastic syndrome.
Read the detailed description
OBJECTIVES:
- Determine whether the combination of epoetin alfa and thalidomide improves the anemia and/or decreases the need for red cell transfusion in patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine whether this regimen improves the bone marrow morphology and cytogenetics, alters the natural history of the disease, and reduces the frequency of leukemic transformation in these patients.
- Evaluate whether this regimen improves pathophysiologic parameters (e.g., apoptosis, tumor necrosis factor-alpha concentration, microvessel density, vascular endothelial growth factor, and cytotoxic T lymphocytes) in the bone marrow of these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive epoetin alfa subcutaneously (SC) once weekly for 8 weeks. After 8 weeks, patients unresponsive to epoetin alfa alone receive oral thalidomide once daily in addition to epoetin alfa SC once weekly for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 2 years..
- Being tested
- epoetin alfa, thalidomide
- Keywords
- de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, previously treated myelodysplastic syndromes, anemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes
- Medical subject headings
- Anemia, Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaBiological
thalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startJun 2001
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Fallon Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Laszlo Leb, MD, Study chair, Fallon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053001
- Sponsor's protocol ID
- FALLON-PR01-09-010
- Other IDs
- CDR0000258753, CELGENE-PR01-09-010, ORTHO-PR01-09-010, FALLON-757
- Status last verified
- Oct 2007
- First submitted
- 27 Jan 2003
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study on the Effectiveness of Thalomid (Thalidomide) Combined With Procrit (Erythropoietin) for the Treatment of Anemia in Patients With Low and Intermediate Risk-1 (IPSS Score Less Than or Equal to 1.5) Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00053001
- Acronym / sponsor ID
- FALLON-PR01-09-010
- Keywords
- de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, previously treated myelodysplastic syndromes, anemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fallon ClinicIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Jan 2003 (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.
RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve anemia, decrease the need for blood transfusions, and improve the quality of life in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa in treating anemia in patients who have myelodysplastic syndrome.
Detailed description
OBJECTIVES:
- Determine whether the combination of epoetin alfa and thalidomide improves the anemia and/or decreases the need for red cell transfusion in patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine whether this regimen improves the bone marrow morphology and cytogenetics, alters the natural history of the disease, and reduces the frequency of leukemic transformation in these patients.
- Evaluate whether this regimen improves pathophysiologic parameters (e.g., apoptosis, tumor necrosis factor-alpha concentration, microvessel density, vascular endothelial growth factor, and cytotoxic T lymphocytes) in the bone marrow of these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive epoetin alfa subcutaneously (SC) once weekly for 8 weeks. After 8 weeks, patients unresponsive to epoetin alfa alone receive oral thalidomide once daily in addition to epoetin alfa SC once weekly for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 2 years..
Study design
- Primary purpose
- Supportive care
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| epoetin alfa | Biological | – |
| thalidomide | Drug | – |
Primary outcome
Clinical response
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 26 Jun 2013.
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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.
Laszlo Leb, MD study chair
Fallon Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epoetin alfa and thalidomide in people with Anemia and Leukemia, run by Fallon Clinic at 2 sites 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?
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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Clinical response. 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 26 Jun 2013.