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The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma.
This is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages: screening, treatment and follow-up period. The screening period was 28 days before the first dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy during treatment. Objective effective rate, safety and survival data were observed during the experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered the follow-up period, during which imaging evaluation (enhanced CT at focal site is recommended) was performed at the following intervals: once every 3 months for 2 years, once every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selinexor+RCHOP | Experimental | Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor+RCHOP | Drug | XPO-1 inhibitor selinexor in combination with RCHOP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | CR plus PR | From date of first day of treatment until the date of last day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression Free Survival | From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months |
| OS | Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Li | Contact | 15267115611 | licong@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Cong Li | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhenjiang | 310005 | China |
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| From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months |
| AE and SAE | Adverse event and serious adverse event | From date of first day of treatmentuntil 30 day after last treatment |