Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in Chinese Participants

Lymphoma, Mantle-Cell Clinical Trial

Official title:

An Observational Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053024
• Other study ID #: CR108287
• Secondary ID: 26866138MCL4001
• Status: Completed
• Start date: April 14, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2020
• Source: Xian-Janssen Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study (retrospective and prospective) is to describe participant and disease characteristics and treatment pattern of Bortezomib treated mantle cell lymphoma (MCL) participants in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants that have been hospitalized for MCL after January 1st 2009.

• Biopsy proven MCL as evidenced by histology with either immunohistochemistry (IHC) or t(11,14) translocation

• Retrospective group: Participants who have finished BTZ treatment before the study initiation as judged by participating site physician

• If participant isn't accessible for oral or written informed consent, ICF can be waived after approved by the IRB

• Prospective group: Participants who are on BTZ at the time of study initiation or start BTZ after study initiation

Exclusion Criteria:

• Participants with documented diagnosis of other cancers prior to or at the presence of the diagnosis of MCL

• Participants enrolled in interventional clinical trials of BTZ or any other drug for MCL

• Prospective group: Participants with contraindication listed in the prescribing information of BTZ

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing
China	Peking University Cancer Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	Xiangya Hospital Central South University	Changsha
China	Nanfang Hospital	Guangzhou
China	Jiangsu Province Hospital	NanJing
China	Huashan Hospital Fudan University	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University	Shanghai
China	Blood Disease Hospital of Chinese Academy of Medical Sciences	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Janssen Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic Characteristic of Participants in Prospective Group: Age	Continuous variable (age) will be summarized using descriptive statistics.	Baseline
Primary	Participants Disease Status (newly diagnosed MCL or relapsed/refractory mantel cell lymphoma [rrMCL]) Treated With BTZ	Categorical variable (disease status) will be summarized using a frequency distribution with the number and percentage of participants in each category. Treatment response will be analyzed by this variable if newly diagnosed MCL patients account for more than 20 percent (%) of total.	Baseline
Primary	Eastern Cooperative Oncology Group (ECOG) Performance Status	A worsening in Eastern Cooperative Oncology Group (ECOG) performance status score was defined as greater than or equal to 1-point increase from Baseline. ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.	Baseline
Primary	Ann Arbor Stage	Ann Arbor stage can be obtained from imaging results or directly from admission records. Ann Arbor stage describes areas of involvement; Stage I(IE) - One lymph node region or extralymphatic site (IE); Stage II(IIE)- Two or more lymph node regions or at least one lymph node region plus a single localized extralymphatic site (IIE) on the same side of the diaphragm; stage III (IIIE, IIIS)-Lymph node regions or lymphoid structures (example, thymus,Waldeyer's ring) on both sides of the diaphragm with optional localised extranodal site (IIIE) or spleen (IIIS); stage IV-Diffuse or disseminated extralymphatic organ involvement.	Up to Follow-up (approximately 22 months)
Primary	Prognostic Index Score	Prognostic index will be summarized using descriptive statistics. For each prognostic factor, 0-3 points are given to each patient and points are summed up to a maximum of 11. Participants with 0-3 points are classified as low risk (44% of participants, median overall survival [OS] not reached). Participants with 4-5 points are classified as intermediate risk (35%, median OS 51 months), and patients with 6-11 points as high risk (21%, median OS 29 months).	Baseline
Primary	Demographic Characteristic of Participants in Prospective Group: Gender	Categorical variable (gender) will be summarized using a frequency distribution with the number and percentage of participants in each category.	Baseline
Primary	Treatment pattern of BTZ-treated MCL participants: Route of Administration	Primary MCL therapy with Velcade (BTZ) prior MCL treatment, combined MCL treatment and subsequent MCL treatment to extract the information on route of administration (subcutaneous [SC] or intravenous [IV]) to see if there's any outstanding factor that impacts BTZ's dose/frequency and identify the most popular usage of BTZ.	Up to Follow-up (approximately 22 months)
Primary	Treatment Pattern of Bortezomib (BTZ) Treated MCL participants: Dose	The cumulated dose will be summarized using descriptive statistics.	Up to Follow-up (approximately 22 months)
Primary	Treatment Pattern of Bortezomib (BTZ) Treated MCL Participants: Frequency	The frequency of BTZ will be summarized using a frequency distribution with the number and percentage of participants in each category.	Up to Follow-up (approximately 22 months)
Primary	Treatment Pattern of Bortezomib (BTZ) Treated MCL Participants: Reason of BTZ Initiation/Discontinuation/Dose Adjustment	The reason of BTZ initiation/discontinuation/dose adjustment will be described with respective number of occurrence.	Up to Follow-up (approximately 22 months)
Secondary	Overall Response Rate (ORR)	ORR is defined as the sum of complete response [CR] rate (CR+ unconfirmed complete remission [CRu]) + Partial remission [PR] rate as per International Working Group (IWG 2007) criteria. These response criteria are based on the reduction in the size of the enlarged lymph node as measured by computerized tomography (CT) scan and the extent of bone marrow involvement that is determined by bone marrow aspirate and biopsy. Complete response [CR] defined as disappearance of all evidence of disease; CRu satisfies CR criteria, however any residual lymph node mass greater than (>)1.5 centimeter (cm) in longest transverse dimension or extranodal site of disease (irrespective of size) must have regressed by more than 75% of the product of the longest perpendicular dimensions compared to the pretreatment baseline. PR defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.	Approximately 22 months
Secondary	Complete Response [CR] Rate (CR+ Unconfirmed Complete Remission CRu)	The percentage of participants with CR and CRu in all participants whose treatment response data are available.	Approximately 22 months
Secondary	Partial Remission (PR) Rate	The percentage of participants with PR in all participants whose treatment response data are available.	Approximately 22 months
Secondary	Time to Response (TTR)	Interval between start of treatment to the first day when CR/CRu or PR was observed.	Approximately 22 months
Secondary	Duration of Response (DOR)	Interval from the date the response was documented to the first day that Progressive Disease (PD) was observed in participants with CR/CRu or PR. PD defined as any new lesions or increase by greater than or equal to (>=) 50% of previously involved sites from nadir.	Approximately 22 months
Secondary	Progressive-Free Survival (PFS)	Interval between start of treatment to first day when death or PD was observed. PD defined as any new lesions or increase by >= 50% of previously involved sites from nadir.	Approximately 22 months
Secondary	Overall survival (OS)	Interval from the day of the start of the treatment to death, or the last date when the participant was identified to be alive whichever is late.	Approximately 22 months