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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferinject | Experimental | 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. |
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| remedies | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The hemoglobin response is compared in patients treated with intravenous iron (Ferinject) and in conservatively treated patients. | 13 months |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JunHO Jang, ph.D | Contact | 82-2-3410-0918 | jh21.jang@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| JunHo Jang, ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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