Clinical trial · Interventional
Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT)
Darbepoetin-alpha and i.v. Iron Administration After Autologous Hematopoietic Stem Cell Transplantation : a Prospective Randomized Trial
NCT00557817CI-TRIAL-00002994completedPhase 2 / Phase 3ClinicalTrials.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)
Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell transplantation for hematological malignancies : a prospective randomized trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alpha (Aranesp) | Drug | — | UNRESOLVED |
| Iron saccharate (Venofer) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- 1
- description
- No medication given
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Aranesp 300 µg/15 days
- interventionNames
- Drug: Darbepoetin alpha (Aranesp)
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Aranesp 300 µg/15 days. Venofer 200 mg on days 28, 42, and 56 after the transplant.
- interventionNames
- Drug: Darbepoetin alpha (Aranesp)
- Drug: Iron saccharate (Venofer)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion criteria: * Male or female; female patients must use a reliable contraception method * Age \> 16 yrs and \< 70 yrs * No terminal organ failure * Written informed consent given by patient or his/her guardian if of minor age. * Adequate iron stores (serum ferritin \> 100 µg/L) on day 21 post-transplant. * Adequate marrow recovery, as shown by: neutrophils \> 1,000/µL, platelet transfusion independence * PBSC (not marrow) transplantation Exclusion criteria: * HIV positive * Known allergy to recombinant human erythropoietin or i.v. iron saccharate * Evidence of active hemorrhage, hemolysis, vitamin B12 or folate deficiency on day 28 post-transplant (inclusion into the protocol may then be delayed up until day 42 if the problem is resolved) * Uncontrolled infection, arrythmia or hypertension on day 28 post-transplant (inclusion into the protocol may then be delayed up until day 42 if the problem is resolved) * Evidence of severe iron overload (transferrin saturation \> 60%, serum ferritin \> 2500 µg/L on day 21 post-transplant)
References
Publications (0)
Data not yet available
No reference posted for this study.