Clinical trial NCT05768997: High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 312
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.


Eligibility 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

Primary outcomes:
measure: Mean Hb change
timeFrame: from baseline to 12 weeks
Secondary outcomes:
measure: Hemoglobin response
timeFrame: during 12-week study period
measure: Time to hemoglobin response
timeFrame: during 12-week study period
measure: Proportion of patients requiring RBC transfusion during 12-week study period
timeFrame: during 12-week study period
measure: Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L
timeFrame: during 12-week study period
measure: Safety analysis
timeFrame: during 12-week study period
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Medical Center
Study officials:
References: