Clinical trial · Interventional
Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.
Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders
- 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)
This is a multi-center open label, randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied. The study will be performed according to the ICH-GCP guidelines. In order to be eligible, the patient must consent in writing that he/she agrees to participate in the study. The patient recruitment period is estimated to be no longer than 18 months.
Conditions
Conditions (4)
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 | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neo-Recormon and Venofer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare the mean change in hemoglobin (Hb) concentrations from baseline to EOT (End of treatment ) between the two treatment groups.
Secondary outcomes (7)
- measure
- The percentage of subjects with Hb response defined by an increase in the Hb concentration by at least 20 g/L in the absence of any RBC transfusion.
- measure
- The time needed to obtain a Hb response.
- measure
- The fraction of subjects receiving RBC transfusions during the study period.
- measure
- The dose of rHuEPO used.
- measure
- The effect on iron-status.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
Show eligibility criteria text
Inclusion Criteria: * Multiple myeloma, indolent NHL or CLL * Anemia of cancer with a Hb concentration within the range ³ 90 - £ 110 g/L measured at two different occasions with at least two weeks interval but inclusion within 4 weeks after the first Hb measurement. * Age \>18 years. * Informed consent in writing. * Demonstration of stainable iron in bone-marrow aspirate. Exclusion Criteria: * Planned or expected antineoplastic therapy (except systemic low dose maintenance corticosteroids) within the 6 weeks following inclusion. * Cytostatic or any other antitumor therapy (except systemic low dose maintenance corticosteroids) within 8 weeks before inclusion. * RBC transfusion within 8 weeks before inclusion. * RHuEPO treatment within 12 weeks before inclusion. * Any iron therapy within 4 weeks before inclusion. * Ongoing infectious disease. * Active inflammatory disease other than the malignant disease. * Performance status ³ 3 according to the ECOG scale. * Folate deficiency (S-folate \< 4,5 nmol/L). * B12 deficiency (S-cobalamin \< 145 pmol/L). * Ongoing haemolysis defined as S-haptoglobin \< 0,2 g/L * Impaired kidney function (S-Creatinine \> 175 mmol/L) * Acute or chronic clinical relevant hepatic dysfunction (S-bilirubin \>40 umol/L) * S-Ferritin \>800 ug/L * Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia. * Unstable or uncontrolled disease related to or affecting cardiac function e.g., unstable angina, congestive heart failure (NYHA\>Class ll), uncontrolled hypertension (diastolic BP \>100 mmHg) and/or uncontrolled cardiac arrhythmia. * Known history of allergy to any of the study medications or their excipients. * Concurrent treatment with experimental drugs not approved by Läkemedelsverket. * Male and female patients with reproductive potential must use an approved contraceptive method (e.g. intrauterine device (IUD), birth control pills or barrier device) during the study and for 3 months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
References
Publications (1)
- BACKGROUNDAuerbach M, Ballard H, Trout JR, McIlwain M, Ackerman A, Bahrain H, Balan S, Barker L, Rana J. Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. J Clin Oncol. 2004 Apr 1;22(7):1301-7. doi: 10.1200/JCO.2004.08.119. PMID 15051778