Clinical trial · Interventional
Thalidomide in Treating Patients With Myelodysplastic Syndrome
Phase II Study of Thalidomide in the Treatment of Myelodysplastic Syndromes in Adults: A Clinical and Biologic Study
NCT00015990CI-TRIAL-00009095completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase II trial to study the effectiveness of thalidomide in treating patients who have myelodysplastic syndrome. Thalidomide may improve the immune system's ability to fight myelodysplastic syndrome
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| de Novo Myelodysplastic Syndromes | — | UNRESOLVED | — |
| Previously Treated Myelodysplastic Syndromes | Myelodysplastic Syndrome | CURATED_BROADER | 0.78 |
| Refractory Anemia | — | UNRESOLVED | — |
| Refractory Anemia With Excess Blasts | Myelodysplastic Syndrome with Excess Blasts | ALIAS | 0.90 |
| Refractory Anemia With Excess Blasts in Transformation | — | UNRESOLVED | — |
| Refractory Anemia With Ringed Sideroblasts | Myelodysplastic Syndrome with Ring Sideroblasts | ALIAS | 0.90 |
| Secondary Myelodysplastic Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (thalidomide)
- description
- Patients receive oral thalidomide once daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: thalidomide
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Confirmed response defined as complete hematologic response (CHR) or partial response (PR) or hematological improvement (HI) on 2 consecutive evaluations in terms of proportion of successes measured using criteria reported by Cheson et al
- timeFrame
- Up to 3 months
- description
- Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
- measure
- Incidence and severity of toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pre-transfusion hemoglobin =\< 10 g/dL * Pre-transfusion platelet count =\< 50,000/μL * Absolute neutrophil count \< 1000/μL * Total bilirubin ≤ 1.5 x UNL * Alkaline phosphatase ≤ 3 x UNL * AST ≤ 3 x UNL * Creatinine ≤ 1.5 x UNL * A diagnosis of MDS as demonstrated in the bone marrow; any subtypes are eligible including: * Refractory anemia (cytopenia) * Refractory anemia with ringed sideroblasts * Chronic myelomonocytic leukemia * Refractory anemia with excess blasts * Refractory anemia with excess blasts in transformation * Unclassified MDS * Patients with refractory anemia with excess blasts in transformation who are not candidates for (or who decline) induction chemotherapy are eligible; those patients who were candidates for (and accepted) induction chemotherapy should have failed at least 1 chemotherapy regimen prior to entry * Patients who are candidates for marrow transplantation should have this option discussed prior to study entry Exclusion Criteria: * Any of the following as this regimen may be harmful to a developing fetus or nursing child: * Pregnant women * Nursing women * Women of childbearing potential or their sexual partners who are unwilling to employ 2 adequate methods of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) * Peripheral neuropathy (by history or clinical exam) * Concomitant therapy ≤ 30 days for myelodysplastic syndrome with any specific agent including chemotherapy, corticosteroids and/or growth factors (i.e. erythropoietin, G-CSF, GM-CSF, thrombopoietic agent); patients on chronic low-dose corticosteriods (\< 20 mg/d) for reasons other than MDS are allowed * Uncontrolled infections
References
Publications (0)
Data not yet available
No reference posted for this study.