Description:
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by
overall response rate at 7 months
Title
- Brief Title: To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
- Official Title: A Phase 3, Randomised, Parallel-group, Active-controlled, Double-blind Study to Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
CT-P10 3.4
- NCT ID:
NCT02260804
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| CT-P10 | | CT-P10 |
| Rituxan | | Rituxan |
Purpose
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by
overall response rate at 7 months
Trial Arms
| Name | Type | Description | Interventions |
|---|
| CT-P10 | Experimental | CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period | |
| Rituxan | Active Comparator | Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period. | |
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma
- Ann Arbor Stage II, III or IV
Exclusion Criteria:
- Has receive rituximab
- Allergies or hypersensitivity to murine, chimeric, human or humanised proteins
- Previous treatment for NHL
- Any malignancy
- Current or recent treatment with any other investigational medicinal product or device
- pregnant or lactating
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Primary Efficacy Endpoint - Overall Response Rate by 7 Months |
| Time Frame: | During the Month 7 (up to Maintenance Cycle 3; Week 28) |
| Safety Issue: | |
| Description: | ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression. |
Secondary Outcome Measures
| Measure: | Secondary Efficacy Endpoint - ORR Over the Study Period |
| Time Frame: | up to 27 months |
| Safety Issue: | |
| Description: | ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression. |
| Measure: | Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery) |
| Time Frame: | Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose). |
| Safety Issue: | |
| Description: | B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL. |
| Measure: | Secondary PK Endpoints - Cmax |
| Time Frame: | 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose) |
| Safety Issue: | |
| Description: | |
| Measure: | Secondary PK Endpoints - Ctrough |
| Time Frame: | 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose) |
| Safety Issue: | |
| Description: | |
| Measure: | Secondary Efficacy Endpoint - Progression-free Survival (PFS) |
| Time Frame: | Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter). |
| Safety Issue: | |
| Description: | PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses. |
| Measure: | Secondary Efficacy Endpoint - Overall Survival (OS) |
| Time Frame: | Overall study period (median follow-up of 29.2 months) |
| Safety Issue: | |
| Description: | Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses. |
| Measure: | Secondary Efficacy Endpoint - Time-to Progression (TTP) |
| Time Frame: | Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter). |
| Safety Issue: | |
| Description: | Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses. |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Celltrion |
Last Updated
April 7, 2021
