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This is a single arm, open, single-center clinical study. The patients who are diagnosed with lymphoma and intend to undergo ASCT will be enrolled. The aim of this study is to investigate the efficacy and safety of the conditioning regimen using mitoxantrone hydrochloride liposome, BCNU, etoposide and cytarabine for ASCT.
High-dose chemotherapy combined with autologous hematopoietic stem cell transplantation (ASCT) is considered the standard of care for patients with chemotherapy-sensitive relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL). BEAM regimen is the most commonly used conditioning regimen for ASCT in lymphoma. But its application is limited by the adverse drug reactions. This present project is a one-arm, open, single-center clinical study. It aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, carmostine, etoposide, and cytarabine as the conditioning regimen for ASCT in patients with lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Improved BEAM regimen | Experimental | The enrolled subjects will received mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine as conditioning regimen for ASCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Improved BEAM regimen | Drug | Mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine will be used as conditioning regimen for ASCT in the lymphoma patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrence rate | The rate of lymphoma relapse | From date of treating with conditioning regimen until lymphoma relapse, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | adverse effects | From date of treating with conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, , assessed up to 36 months. |
| Time of neutrophil implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengcheng He, MD | Contact | 0086-029-85324035 | hepc@163.com | |
| Xiaoyan Zheng, MD | Contact | 0086-15829370502 | xiaoy_2008@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Pengcheng He, MD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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|
On the first day of three consecutive days, the peripheral blood neutrophil count (ANC) was ≥0.5×10^9/L without blood transfusion.
| From date of the treatment with the conditioning regimen until the time of neutrophil implantation or date of death from any cause, whichever came first, assessed up to 36 months. |
| Time of platelet implantation | On the first day of three consecutive days, the peripheral blood platelet count (PLT) was ≥20×10^9/L without blood transfusion. | From date of the treatment with the conditioning regimen until the time of platelet implantation or date of death from any cause, whichever came first, assessed up to 36 months. |
| OS | Overall survival | From date of treating with conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, , assessed up to 36 months. |
| PFS | Progression free survival | From date of treating with conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, , assessed up to 36 months. |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |