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GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)

Primary Purpose

Classic Hodgkin's Lymphoma, Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

GLS-010

Chemotherapy of Investigator's choice

About this trial

This is an interventional treatment trial for Classic Hodgkin's Lymphoma focused on measuring GLS-010, relapsed or refractory classic Hodgkin's lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Signed written informed consent form (ICF).
Age of ≥ 18 years at the time of enrollment.
Histologically confirmed classic Hodgkin's lymphoma (cHL).
Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.
Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment
Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of ≥ 12 weeks.
Have adequate hematologic and organ function .

Key Exclusion Criteria:

Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.
Central nervous system lymphoma invasion.
Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.
Prior exposure to any anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137,anti-CTLA-4 antibody, or any other antibody or drug target for T cell co-stimulatory or checkpoint pathways.
Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Subjects with other malignancy within 5 years prior to the first dose of study treatment, except for Cervical carcinoma in situ and Cured basal cell carcinoma of the skin.
Have received chemotherapy, radiotherapy, molecular-targeted therapy or major surgery within 4 weeks prior to the first dose of study treatmen; Clinically significant AE associated with previous treatment has not returned to baseline or ≤1 (except hair loss).
Pregnant or breast-feeding women.
Patients are unsuitable for the study evaluated by investigator.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GLS-010

chemotherapy

Arm Description

GLS-010 therapy

chemotherapy

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014

Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.

Secondary Outcome Measures

Overall Survival (OS)

Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason

Objective Response Rate (ORR)

ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.

Disease Control Rate (DCR)

DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014.

Duration of Response (DoR)

Up to 2 years

Time to Response (TTR)

Up to 2 years

Full Information

NCT ID

NCT05518318

First Posted

August 19, 2022

Last Updated

August 24, 2022

Sponsor

Guangzhou Gloria Biosciences Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05518318

Brief Title

GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)

Official Title

Evaluate the Efficacy and Safety of GLS-010 Versus Chemotherapy Assessed by Investigator in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL) in a Randomized, Open, Multicenter Phase III Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangzhou Gloria Biosciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Classic Hodgkin's Lymphoma, Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma

Keywords

GLS-010, relapsed or refractory classic Hodgkin's lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GLS-010

Arm Type

Experimental

Arm Description

GLS-010 therapy

Arm Title

chemotherapy

Arm Type

Active Comparator

Arm Description

chemotherapy

Intervention Type

Drug

Intervention Name(s)

GLS-010

Other Intervention Name(s)

GLS-010 therapy

Intervention Description

Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W

Intervention Type

Drug

Intervention Name(s)

Chemotherapy of Investigator's choice

Intervention Description

Chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014

Description

Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason

Time Frame

Up to 2 years

Title

Objective Response Rate (ORR)

Description

ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.

Time Frame

Up to 2 years

Title

Disease Control Rate (DCR)

Description

DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014.

Time Frame

Up to 2 years

Title

Duration of Response (DoR)

Description

Up to 2 years

Time Frame

DoR defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first

Title

Time to Response (TTR)

Description

Up to 2 years

Time Frame

TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on Lugano Classification 2014

Other Pre-specified Outcome Measures:

Title

Number of subjects with adverse events (AEs)

Description

Up to 2 years

Time Frame

From the time of signed informed consent through 90 days after the last dose of GLS-010

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Signed written informed consent form (ICF). Age of ≥ 18 years at the time of enrollment. Histologically confirmed classic Hodgkin's lymphoma (cHL). Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy. Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy of ≥ 12 weeks. Have adequate hematologic and organ function . Key Exclusion Criteria: Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma. Central nervous system lymphoma invasion. Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period. Prior exposure to any anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137,anti-CTLA-4 antibody, or any other antibody or drug target for T cell co-stimulatory or checkpoint pathways. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subjects with other malignancy within 5 years prior to the first dose of study treatment, except for Cervical carcinoma in situ and Cured basal cell carcinoma of the skin. Have received chemotherapy, radiotherapy, molecular-targeted therapy or major surgery within 4 weeks prior to the first dose of study treatmen; Clinically significant AE associated with previous treatment has not returned to baseline or ≤1 (except hair loss). Pregnant or breast-feeding women. Patients are unsuitable for the study evaluated by investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ting lu

Phone

0086-10-88196391

luting_1010@163.com

12. IPD Sharing Statement

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GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)

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