Combining high-dose IV iron with ESA for treating chemotherapy-induced anemia
Prospective, Multicenter, Randomized Phase 3 Trial of High Dose IV Iron in Combination of Erythrocytosis Stimulating Agents in Chemotherapy Induced Anemia With Functional Iron Deficiency
This study is testing if combining high-dose iron with a medication that helps make red blood cells can better treat anemia in cancer patients who have had chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hallym University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Anyang-si) |
| Trial ID | NCT05768997 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, randomized phase 3 clinical study aims to evaluate the efficacy and safety of a combination treatment of erythropoiesis-stimulating agent (ESA) and high-dose intravenous iron in patients suffering from chemotherapy-induced anemia with functional iron deficiency. Participants will be randomly assigned to receive either the combination treatment or ESA alone. The study focuses on patients with advanced or metastatic solid cancers who have recently undergone myelosuppressive chemotherapy. The primary goal is to determine if the combination therapy improves hemoglobin levels more effectively than ESA monotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with advanced or metastatic solid cancer who have anemia due to functional iron deficiency.
Not a fit: Patients with absolute iron deficiency or other causes of anemia unrelated to chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve hemoglobin levels and overall quality of life for patients with chemotherapy-induced anemia.
How similar studies have performed: Previous studies have shown promising results with similar combination therapies in managing anemia, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patient who has signed a written consent
* Age ≥ 19 ③ Histologically diagnosed advanced/metastatic solid cancer
* Patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study
* Anemia with functional iron deficiency
1. Hemoglobin \<10g/dL
2. functional iron deficiency: transferrin saturation \<50% AND serum ferritin 30-800ng/mL ⑤ ECOG performance status 0-2 ⑥ life expectancy ≥ 24weeks
Exclusion Criteria:
* Absolute iron deficiency (serum ferritin \<30 ng/mL AND transferrin saturation \<20%) or no iron deficiency (serum ferritin ≥800 ng/mL OR transferrin saturation ≥50%)
* If there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin B12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.)
* Ongoing bleeding at the time of study registration
* Patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia)
* Presence of bone marrow tumor invasion
* Receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration
* History of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration
* Past or family history of hemochromatosis ⑨ History of hypersensitivity to iron treatment or erythropoiesis stimulating agents ⑩ Uncontrolled acute or chronic infection ⑪ Renal dysfunction (serum creatinine ≥2.0 mg/dL, or glomerular filtration rate \<30 mL/min/1.73 m2) or liver dysfuction (AST or ALT 3 times or more the upper limit of normal) ⑫ Pregnant or lactating women
Where this trial is running
Anyang-si
- Hallym University Medical Center — Anyang-si, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Dae Young Zang, Ph.D.
- Email: fhdzang@gmail.com
- Phone: +82-31-380-3704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.