Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIL62 + Lenalidomide | Experimental | MIL62 plus Lenalidomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62 Injection | Drug | 1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Objective Response of Complete Response | Percentage of Participants With an Objective Response of Complete Response | Baseline to 1 month after the last dose of last patient |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate of Duration of Response | Kaplan-Meier Estimate of Duration of Response | Baseline to 1 month after the last dose of last patient |
| Percentage of Participants With Disease Control |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, MD | Contact | (+86)010-87788293 | syuankaipumc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, MD | Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing | Principal Investigator |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lenalidomide | Drug | Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction |
|
|
Percentage of Participants With Disease Control
| Baseline to 1 month after the last dose of last patient |
| Participants With 1 Year Progression Free Survival | Participants With 1 Year Progression Free Survival | Baseline to 1 month after the last dose of last patient |
| Number of Participants With Treatment Emergent Adverse Events | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided