Clinical trial · Interventional
Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple 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)
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| darbepoetin alfa | Drug | — | UNRESOLVED |
| epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Darbepoetin alfa
- description
- darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.
- interventionNames
- Drug: darbepoetin alfa
- type
- ACTIVE_COMPARATOR
- label
- Epoetin alfa
- description
- epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.
- interventionNames
- Drug: epoetin alfa
Primary outcomes (1)
- measure
- Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of a non-myeloid malignancy * Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy * Hemoglobin no greater than 11.0 g/dL * 18 and over * ECOG 0-2 * Bilirubin less than 2 times upper limit of normal (ULN) * Creatinine less than 2 times ULN * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * More than 30 days since prior darbepoetin alfa or epoetin alfa * More than 30 days since prior participation in investigational device or drug trials Exclusion Criteria: * The following diagnoses are excluded: * Acute myeloid leukemia * Chronic myeloid leukemia * Acute lymphoblastic leukemia * Hairy cell leukemia * Burkitt's lymphoma * Lymphoblastic lymphoma * other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia) * angina * congestive heart failure * New York Heart Association class III or IV heart disease * hypertension * cardiac arrhythmia * other unstable or uncontrolled disease or condition that would affect cardiac function * pregnant or nursing * known seizure disorder * known sensitivity to study agents * clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease) * confirmed neutralizing antibodies to epoetin alfa * other disorder that would preclude study compliance or giving informed consent * other concurrent epoetin alfas * prior randomization to this study * other concurrent investigational agents or procedures
References
Publications (1)
- RESULT20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570. PMID 16710026