- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187716
Intravenous Iron Injection in Cancer Patients With Anemia
Multicenter Randomized Study on the Efficacy of Intravenous Iron Injection in Cancer Patients With Anemia
- Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
- Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
- Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
- In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.
- Improvement of anemia and the improvement of quality of life compared to conservative treatment of intravenous iron
Study Overview
Detailed Description
This study is a comparative clinical trial of prospective, multicenter, randomized trials to evaluate the efficacy of intravenous iron (Ferinject®) in cancer patients with anemia.
Changes in hemoglobin in the treated and conservative treatment groups with a single intravenous Ferrinject® in patients with anemia by chemotherapy are identified.
Clinical Drug Ferinject Injection For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle.
Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject.
- The administration of ferinject is a single dose, no re-administration. If chemotherapy is not performed, it can be administered at any time if the selection and exclusion criteria are met.
- The administration period for ferinject should be administered within 24 hours or 24 hours after the day 1 of the chemotherapy cycle based on the results of phase 2 studies
- remedies Within the period of sample collection of visits 2 to 4 after study enrollment, if the physician determines that treatment for clinically meaningful anemia is necessary, treatment for anemia other than ferinjects will be followed. Treatment for anemia will include remedies such as iron (oral or intravenous), hematopoietic accelerators, and blood transfusions, and will be determined by researchers at each institution to provide optimal treatment for patients. At the time this treatment is administered, the subject will be dropped from the clinical trial.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: JunHo Jang, ph.D
- Phone Number: 82-2-3410-0918
- Email: jh21.jang@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- JunHo Jang, ph.D
- Phone Number: 82-2-3410-0918
- Email: jh21.jang@samsung.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The subject should be diagnosed with solid cancer or lymphoma. Hemoglobin level of test subject should be in the range of 8.0-10.5g / dL, or he / she has experienced hemoglobin reduction of 2g / dL or more during chemotherapy.
Exclusion Criteria:
The patients have a history of iron (oral or intravenous), hematopoietic stimulating agents (ESA), and dialysis within 4 weeks of study enrollment.
There is evidence that the patient's disease is a bone marrow invasion. There is a hypersensitivity reaction to ferinject or the components of ferinject.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ferinject
For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle. Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject. |
For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle. Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject. |
Other: remedies
Treatment for anemia will include remedies such as iron (oral or intravenous), hematopoietic accelerators, and blood transfusions, and will be determined by researchers at each institution to provide optimal treatment for patients.
|
For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle. Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The hemoglobin response is compared in patients treated with intravenous iron (Ferinject) and in conservatively treated patients.
Time Frame: 13 months
|
13 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: JunHo Jang, ph.D, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-04-182-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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