Clinical trial · Interventional
Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
NCT00217386CI-TRIAL-00003914completedPhase 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)
RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin together with etanercept may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| etanercept | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Response rate
- measure
- Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
- measure
- Identify parameters that are associated with a high probability of response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of myelodysplastic syndromes (MDS)
* Low- or intermediate-1-risk disease, as defined by International Prognostic Scoring System (IPSS) criteria, meeting 1 of the following criteria:
* Single or multilineage cytopenia, as defined by all of the following:
* Absolute neutrophil count \< 1,500/mm\^3
* Hemoglobin \< 10 g/dL
* Platelet count \< 100,000/mm\^3
* Transfusion requirement of ≥ 2 units of packed red blood cells within an 8-week period
* Not eligible for stem cell transplantation due to any of the following reasons:
* No suitable bone marrow donor available
* Not eligible for a transplantation protocol
* Not willing to undergo transplantation
* No intermediate-2- or high-risk MDS
* No chronic myelomonocytic leukemia
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Not specified
Renal
* Not specified
Pulmonary
* No pneumonia within the past 2 weeks
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other severe disease that would preclude study compliance
* No other active severe infection (e.g., septicemia) within the past 2 weeks
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior and no concurrent hematopoietic growth factors for MDS
* More than 4 weeks since prior immunomodulatory therapy for MDS
* No prior anti-thymocyte globulin
* No prior hematopoietic stem cell transplantation
* No other concurrent immunomodulatory therapy for MDS
Chemotherapy
* Not specified
Endocrine therapy
* Prednisone \< 5 mg/day allowed
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 4 weeks since prior and no concurrent cytotoxic therapy for MDS
* More than 4 weeks since prior experimental therapy for MDS
* No other concurrent experimental therapy for MDSReferences
Publications (0)
Data not yet available
No reference posted for this study.