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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Sun Yat-sen University | OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
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To evaluate the efficacy and adverse effects of lenalidomide combined with G-CHOP(LO-CHOP) in the treatment of newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL).
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (Complete response, Overall Survival, Progression Free Survival) and adverse effects of lenalidomide combined with G-CHOP(LO-CHOP) in the treatment of newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LO-CHOP | Experimental | Lenalidomide combined with G-CHOP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide combined with G-CHOP (LO CHOP) | Drug | Lenalidomide combined with G-CHOP to treat newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria. | Up to 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. | From the randomization until the first documentation of PD or death whichever occurs first or up to 28 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xu, PhD | Contact | +86 187 5091 8842 | xubingzhangjian@126.com | |
| Zhifeng Li | Contact | +86 136 0690 1162 | lzf_xm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Xu, PhD | The First Aiffiliated hosptical of xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bing Xu | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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| Fujian Cancer Hospital |
| OTHER_GOV |
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| Overall survival |
OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point. |
| Up to 28 months |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |