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| Name | Class |
|---|---|
| National Institute of Food and Drug Safety Evaluation (Republic of Korea) | UNKNOWN |
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This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melphalan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan | Drug | The subject receives conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation. Dosage of melphalan is 50mg/m^2/day. Infuse Melphalan over 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Melphalan concentration | Analysis: Maximum Concentration observed (Cmax) | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI |
| Melphalan concentration | Analysis: Time of Maximum concentration observed (Tmax) | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI |
| Melphalan concentration | Analysis: Area Under the Curve | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI |
| Melphalan concentration | Analysis: Half lite (T1/2) | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyoung Jin Kang, MD | Contact | +82-2-2072-3452 | kanghj@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyoung Jin Kang, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42053946 | Derived | Choi JY, Kim B, Park HJ, Kim BK, Hong KT, Lee S, Lee S, Kang HJ. Population Pharmacokinetics of Melphalan in Pediatric Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation with Various Conditioning Regimens. Eur J Drug Metab Pharmacokinet. 2026 Jul;51(4):391-400. doi: 10.1007/s13318-026-01000-6. Epub 2026 Apr 29. |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D018380 | Hematopoietic Stem Cell Transplantation |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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|
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |