Clinical trial · Interventional
Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Biological | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
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