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This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide | Experimental |
| |
| lenalinomide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide | Drug | The patients confirming to the eligibility criteria will receive MIL62 from cycle 1 to cycle 30 and lenalidomide from cycle 1 to cycle 18, unless either rapid disease progression or unacceptable toxicity was observed. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (per IRC) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (per Investigator) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Overall Survival | From date of randomization Until date of death from any cause for up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, doctor | Contact | 8610-87788293 | syuankaipumc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39007066 | Derived | Shi Y, Zhou K, Zhou H, Qin Y, Jing H, Xiang Y, Wang Z, Wang Z, Zang A, Bai O, Li Z, Zhang H, Song Y, Liang J, Wei M. Efficacy and safety of MIL62, a novel glycoengineered type â…¡ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial. EClinicalMedicine. 2024 Jun 20;73:102702. doi: 10.1016/j.eclinm.2024.102702. eCollection 2024 Jul. |
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|
| lenalinomide | Drug | The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed. |
|
| Overall Response Rate (ORR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years |
| Kaplan-Meier Estimate of Duration of Response | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years |
| Percentage of Participants With Disease Control | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years |
| Number of Participants With Treatment Emergent Adverse Events | up to the 1 month the last dose of last subject |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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