Clinical trial · Interventional
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
NCT00230321CI-TRIAL-00009294completedPhase 1 / Phase 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)
The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin alfa.
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 |
|---|---|---|---|
| Blood Cancer | Liquid Tumor | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelodysplastic Syndromes (MDS) | Myelodysplastic Syndrome | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Darbepoetin alfa
- description
- During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously for 6 weeks. The dosage for the remaining treatment is dependent of patients response during the induction phase.
- interventionNames
- Drug: Darbepoetin alfa
Primary outcomes (2)
- measure
- hemoglobin and/or red blood cell (RBC) transfusion-dependence.
- measure
- To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in
Secondary outcomes (2)
- measure
- To assess bone marrow progenitor BFU-E growth before and after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:- Diagnosis: * Bone marrow aspirate/biopsy-proven MDS for \> 2 months prior to enrollment. * MDS French-American-British (FAB) subtypes refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), and non-proliferative chronic myelomonocytic leukemia (CMML) \[WBC \< 12,000/ml\]. * Patients must have an untransfused hemoglobin \< 10.0 g/dL and/or patients must be red cell transfusion-dependent for a period of at least 2 months prior to study entry. \- Laboratory: * Bilirubin \< or = to 2 mg/dL * ALT/SGPT \< or = to 2.5 x the upper limit of normal (ULN) * Normal renal function (Stanford: serum creatinine \< 1.2 mg/dL \[male\], \< 1.0 mg/dL \[female\]; Vanderbilt: \< 1.5 mg/dL). * Age: \> or = to 18 * Other: * ECOG performance status 0-2. * Patients may receive standard supportive care, including transfusions and antibiotics as required. * Patients must be r-HuEPO naive or must not have received prior treatment with r-HuEPO \> or = to 40,000 U/week for more than 4 weeks. Exclusion Criteria:- Patients with secondary MDS or prior allogeneic bone marrow transplant.
References
Publications (0)
Data not yet available
No reference posted for this study.