Clinical trial · Interventional
Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy
A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy
- 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 purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Non-Myeloid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alfa | Drug | — | UNRESOLVED |
| rHuEPO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- rHuEPO
- interventionNames
- Drug: rHuEPO
- type
- EXPERIMENTAL
- label
- Darbepoetin alfa
- interventionNames
- Drug: Darbepoetin alfa
Primary outcomes (1)
- measure
- Time to hematopoietic response during the comparative treatment period
- timeFrame
- during the comparative treatment period
Secondary outcomes (9)
- measure
- Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more * Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy * Karnofsky performance status of greater than or equal to 50% * Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL Exclusion Criteria: * Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes * Hematologic disorder previously associated with anemia * Active bleeding * Iron deficiency * Received erythropoietic therapy within 14 days prior to randomization * Unstable cardiac disease * Known positive human immunodeficiency virus antibody or hepatitis B surface antigen * Known positive antibody response to any erythropoietic agent * Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication * Pregnant or breast feeding * Red blood cell (RBC) transfusion within 4 weeks of screening * Known hypersensitivity to any recombinant mammalian-derived product
References
Publications (0)
Data not yet available