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

Xian-Janssen Pharmaceutical Ltd.54 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lymphoma, Mantle-Cell

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

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

Outcomes

Primary Outcomes

Demographic Characteristic of Participants in Prospective Group: Age

Continuous variable (age) will be summarized using descriptive statistics.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Up to Follow-up (approximately 22 months)

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).

Data from ClinicalTrials.gov

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Secondary Outcomes

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.