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| Name | Class |
|---|---|
| Kyoto University Hospital | OTHER |
| Hokkaido University Hospital | OTHER |
| Okayama University | OTHER |
| Tokai University |
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This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with PPMX-T003 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPMX-T003 | Drug | The therapeutic agent is administered continuously intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course) | In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the first course, incidence of AEs and DLTs by the treatment are measured. | 7days after the administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later) | In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the second course or later, incidence of AEs and DLTs by the treatment are measured. | From the second course to the final course (Max. 35days after the first administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiyoshi Ando | Contact | +81 82-257-5555 | andok@keyaki.cc.u-tokai.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiroshima University Hospital | Recruiting | Hiroshima | Hiroshima | 734-8551 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40588385 | Derived | Fukuhara N, Onizuka M, Kanda J, Asada N, Kato K, Ando K. Protocol for a multicentre, open-label, dose-escalation phase I/II study evaluating the tolerability, safety, efficacy and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with aggressive natural killer cell leukaemia. BMJ Open. 2025 Jun 30;15(6):e098532. doi: 10.1136/bmjopen-2024-098532. |
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| ID | Term |
|---|---|
| D054066 | Leukemia, Large Granular Lymphocytic |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| Kyushu University | OTHER |
| Tohoku University | OTHER |
| Nagoya University | OTHER |
| Komagome Hospital | OTHER |
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| Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan | As a part of efficacy evaluation of the treatment, percentage change in the product of the maximum long and short diameters of the liver measured by CT (assessed by the primary physician) | 35 days |
| Efficacy of PPMX-T003 repeated continuous intravenous administration (2) improvement in liver function as assessed by the Model for End-stage Liver Disease (MELD and MELD-Na) | 35 days |
| Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months | 6 months |
| Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy | 35days after the treatment |
| Serum drug concentration during repeated continuous intravenous PPMX-T003 administration | 35 days |
| Anti-drug antibody production (Immunogenicity) | 35 days |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |