The primary objective of this study was to evaluate the efficacy of tislelizumab assessed by Independent Review Committee (IRC) in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification
This was an open-label, single-arm, multi-center Phase 2 study. Response was to be assessed by PET(positron emission tomography) and computed tomography (CT) scan per the Lugano Classification. CT scan with contrast and Positron emission tomography (PET)/CT was used as required by protocol, until progressive disease (PD), new anti-cancer therapy, withdrawal of consent, death, lost to follow-up, or end of study (EOS), whichever occurred first. Total body magnetic resonance imaging (MRI) was allowed if CT with contrast is contraindicated. During treatment with immune checkpoint inhibitor such as with tislelizumab, pseudo-progression may occur due to immune cell infiltration and other mechanisms as manifested by apparent increase of existing tumor masses or appearance of new tumor lesions. Participants were allowed to continue study treatment if there is suspicion of pseudo-progression, provided they are asymptomatic and have radiographic progression only, until a second consecutive CT scan demonstrates PD at which time study treatment was discontinued permanently. Participants were evaluated for Adverse Events (AEs) (all Grades per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03 \[NCI CTCAE v. 4.03\]), serious AEs (SAEs), and any AEs requiring study drug interruption or discontinuation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Administered as specified in the treatment arm
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by Independent Review committee (IRC) per the Lugano Classification
Time frame: From the date of first dose Up to approximately 3 year and 7 months
Progression-free Survival (PFS)
PFS is defined as the time from the first dose of tislelizumab to the date of Progressive Disease (PD) or death, whichever occurs first, assessed by IRC per the Lugano Classification
Time frame: From the date of first dose until end of study (Up to approximately 3 years and 7 months)
Duration of Response (DOR)
DOR is defined as the time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first, assessed by IRC per the Lugano Classification
Time frame: From the date of first dose until end of study (Up to approximately 3 years and 7 months)
Rate of Complete Response (CRR)
CRR is defined as the percentage of participants who achieve a best response of CR, assessed by IRC per the Lugano Classification
Time frame: From the date of first dose until end of study (Up to approximately 3 years and 7 months)
Time to Response (TTR)
TTR is defined as the time from the date of the first dose of tislelizumab to the time the response criteria are first met, assessed by IRC per the Lugano Classification
Time frame: From the date of first dose until end of study (Up to approximately 3 years and 7 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
...and 2 more locations
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. An SAE is any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening. * Requires hospitalization or prolongation of existing hospitalization * Results in disability/incapacity * Is a congenital anomaly/birth defect * Is considered a significant medical AE by the investigator based on medical judgement
Time frame: From the date of first dose until end of study (Up to approximately 3 years and 7 months)
Number of Participants With Significant Changes in Clinical Laboratory Results
Clinical laboratory (e.g. hematology, serum chemistry, urinalysis) values were evaluated for each laboratory parameter and participants with clinically significant changes are summarized.
Time frame: From the date of first dose until end of study (Up to approximately 3 years and 7 months)
Number of Participants With Significant Changes in Electrocardiograms
Time frame: From the date of first dose until end of study (Up to approximately 3 years and 7 months)