Relapsed/Refractory Follicular Lymphoma
Conditions
Brief summary
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).
Interventions
Sponsors
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 2. At least one measurable lesion (as per Lugano 2014 criteria). 3. Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a. 4. Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody. 5. Adequate hepatic, hematologic, and renal function. 6. Expected survival at least 6 months.
Exclusion criteria
1. Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation. 2. History of central nervous system (CNS) metastases or active CNS involvement. 3. History of other malignancy within the past 5 years. 4. Severe organic cardiovascular or cerebrovascular diseases. 5. History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies. 6. Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein. 7. Human immunodeficiency virus (HIV) infection. 8. Echocardiography examination indicating left ventricular ejection fraction (LVEF) \< 55%. 9. Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate(CRR) as Assessed by Investigator | approximately 48 months | 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). |
| Progression-Free Survival (PFS) as Assessed by Investigator | approximately 48 months | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC) | approximately 48 months | CRR is defined as the percentage of participants who achieve a CR determined per Lugano 2014 criteria. |
| Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC) | approximately 48 months | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. |
| Objective Response Rate (ORR) | approximately 48 months | ORR is defined as the proportion of the analysis population achieving CR, PR(Partial Response). |
| Duration of Response (DOR) | approximately 48 months | 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. |
| Overall Survival (OS) | approximately 60 months | OS is defined as the time from randomization to death due to any cause. |
| Time to Next Anti-Lymphoma Treatment(TTNT) | approximately 48 months | TTNT is defined as the number of days from randomization to the date of next anti-lymphoma treatment. |
| Adverse Event (AE) | approximately 48 months | 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. |
Countries
China
Contacts
CONTACTYuqin Song, Professor
Outcome results
None listed