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

NCT03053024 | Completed

• 2 other identifiers: CR10828726866138MCL4001
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Lymphoma, Mantle-Cell

Outcome Measures

Primary Outcomes (10)

• Demographic Characteristic of Participants in Prospective Group: Age

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

  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.

  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.

  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.

  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).

  Baseline

• 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

• 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)

• 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)

• 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)

• 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 Outcomes (7)

• Overall Response Rate (ORR)

  Approximately 22 months

• Complete Response [CR] Rate (CR+ Unconfirmed Complete Remission CRu)

  Approximately 22 months

• Partial Remission (PR) Rate

  Approximately 22 months

• Time to Response (TTR)

  Approximately 22 months

• Duration of Response (DOR)

  Approximately 22 months

Study Arms (2)

Cohort 1: Relapse/refractory MCL (rrMCL ) Participants

Participants characteristics and treatment pattern of relapsed/refractory mantel cell lymphoma \[rrMCL\]) participants treated by Bortezomib (BTZ) will be observed for cohort 1.

Cohort 2: Newly Diagnosed MCL Participants

Participants characteristics and treatment pattern of newly diagnosed MCL participants (if more than 20% of total BTZ-treated MCL) will be analysed for cohort 2.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study include mantle cell lymphoma (MCL) participants who were or will be treated by Bortezomib (BTZ) per routine clinical care in multiple tertiary care hospitals after January 1st 2009. Both newly diagnosed MCL participants and relapsed/refractory MCL participants will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (9)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Peking University Cancer Hospital

Beijing, 100142, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

Nanfang Hospital

Guangzhou, 510515, China

Location

Jiangsu Province Hospital

Nanjing, 210029, China

Location

Ruijin Hospital, Shanghai Jiao Tong University

Shanghai, 200025, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Blood Disease Hospital of Chinese Academy of Medical Sciences

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: April 14, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

CN (9)