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This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM0306 in combination with lenalidomide | Experimental | One treatment cycle consists of 4 weeks (28 days). IMM0306 (Amulirafusp Alfa) will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle. |
|
| Placebo in combination with lenalidomide | Placebo Comparator | One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM0306 2.0 mg/kg | Drug | IV infusion; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate(CRR) as Assessed by Investigator | CRR is defined as the percentage of participants who achieve a CR(Complete Response) determined per Lugano 2014 criteria (2014 Lugano Revised Response Criteria for Malignant Lymphoma). | approximately 48 months |
| Progression-Free Survival (PFS) as Assessed by Investigator | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. | approximately 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC) | CRR is defined as the percentage of participants who achieve a CR determined per Lugano 2014 criteria. | approximately 48 months |
| Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqin Song, Professor | Contact | 010-88196118 | SongYQ_VIP@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
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| Placebo | Drug | IV infusion; |
|
| Lenalidomide 20 mg | Drug | orally |
|
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. |
| approximately 48 months |
| Objective Response Rate (ORR) | ORR is defined as the proportion of the analysis population achieving CR, PR(Partial Response). | approximately 48 months |
| Duration of Response (DOR) | DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first. | approximately 48 months |
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | approximately 60 months |
| Time to Next Anti-Lymphoma Treatment(TTNT) | TTNT is defined as the number of days from randomization to the date of next anti-lymphoma treatment. | approximately 48 months |
| Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. | approximately 48 months |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| 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 |
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| 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 |
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