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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a prospective, single arm, multicenter, dose-escalation clinical study to evaluate the safety and efficacy of CMOEP in patients with untreated Peripheral T-cell Lymphoma.
This is a single arm, multicenter, dose-escalation study which mainly explores the dose limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone(CMOEP) in patients with untreated Peripheral T-cell Lymphoma. Liposomal mitoxantrone hydrochloride will be given on day 1 at three different doses (15 mg/m2, 18 mg/m2, 20 mg/m2) and be combined with Cyclophosphamide, Vincristine, Etoposide and Prednisone. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMOEP | Experimental | dose-escalation: Untreated Peripheral T-cell Lymphoma Patients will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone for 6 cycles (planned) (21 days per cycle). The initial dose of liposomal mitoxantrone hydrochloride is 15 mg/m2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lposomal mitoxantrone hydrochloride,Cyclophosphamide,Vincristine,Etoposide and Prednisone(CMOEP) | Drug | Drug: Liposomal mitoxantrone hydrochloride (15 mg/m2, 18 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: Vincristine (1.4mg/ m2,Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle. Drug: Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3 of each 21-day cycle. Drug: Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in CMOEP | Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicities (DLTs) | Adverse events (AE) defined as DLT events per protocol | Cycle 1 (21 days) |
| The incidence of AE and SAE | AE or severe adverse events (SAE) occur since the first dose of therapy is given |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huilai Zhang, MD;PhD | Contact | 086-02223340123 | zhlwgq@126.com | |
| Jingwei Yu, MD;PhD | Contact | 086-02223340123 | jingweiyu@pku.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Insititute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40292284 | Derived | Yu J, Sun X, Gao G, Yu L, Wang J, Qiu L, Qian Z, Li W, Zhang H. CMOEP regimen in the treatment of untreated peripheral T-cell lymphoma: a multicenter, single-arm, phase I study. Front Immunol. 2025 Apr 11;16:1551723. doi: 10.3389/fimmu.2025.1551723. eCollection 2025. |
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No individual patient data will be shared with other researchers
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Up to 28 days after the last patient complete his study therapy |
| Objective response rate (ORR) | Response is assessed according to the lugano criteria | Up to 1 year |
| Complete response rate (CRR) | Response is assessed according to the lugano criteria | Up to 1 year |
| Progression-free survival(PFS) | From the date of the first dose of therapy is given until disease progression, death | Up to 1 year |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |