Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period

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.

375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.

CT-P10

375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.

Rituxan

SungHyun Kim

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

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

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.

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.

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.

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.

Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.

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.

Celltrion

CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period

Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

In this study, TTE endpoints were secondary endpoints and were not powered. As medians of PFS, TTP, and OS were not reached in both treatment groups, longer follow-up is needed to ascertain the median time for TTE parameters of PFS, TTP, and OS.

Dr. Sung Hyun Kim

The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.

Primary Efficacy Endpoint - Overall Response Rate by 7 Months

Secondary Efficacy Endpoint - ORR Over the Study Period

Baseline

Induction Cycle 1 (1hr after end of infusion)

Induction Cycle 2 (predose)

Induction Cycle 3 (predose)

Induction Cycle 4 (predose)

EOT1 (anytime)

Maintenance Cycle 1 (predose)

Maintenance Cycle 1 (1hr after end of infusion)

Maintenance Cycle 2 (predose)

Maintenance Cycle 2 (1hr after end of infusion)

Maintenance Cycle 3 (predose)

The PD population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PD result.

Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)

Induction Cycle 1

Induction Cycle 2

Induction Cycle 3

Induction Cycle 4

Maintenance Cycle 1

Maintenance Cycle 2

The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result.

Spots Global Cancer Trial Database for To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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