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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Xian-Janssen Pharmaceutical Ltd.

Current Primary Outcome:

  • Demographic Characteristic of Participants in Prospective Group: Age [ Time Frame: Baseline ]
    Continuous variable (age) will be summarized using descriptive statistics.
  • Participants Disease Status (newly diagnosed MCL or relapsed/refractory mantel cell lymphoma [rrMCL]) Treated With BTZ [ Time Frame: Baseline ]
    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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline ]
    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.
  • Ann Arbor Stage [ Time Frame: Up to Follow-up (approximately 22 months) ]
    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 sa

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Overall Response Rate (ORR) [ Time Frame: Approximately 22 months ]
      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.
    • Complete Response [CR] Rate (CR+ Unconfirmed Complete Remission CRu) [ Time Frame: Approximately 22 months ]
      The percentage of participants with CR and CRu in all participants whose treatment response data are available.
    • Partial Remission (PR) Rate [ Time Frame: Approximately 22 months ]
      The percentage of participants with PR in all participants whose treatment response data are available.
    • Time to Response (TTR) [ Time Frame: Approximately 22 months ]
      Interval between start of treatment to the first day when CR/CRu or PR was observed.
    • Duration of Response (DOR) [ Time Frame: Approximately 22 months ]
      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.
    • Progressive-Free Survival (PFS) [ Time Frame: Approximately 22 months ]
      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.
    • Overall survival (OS) [ Time Frame: Approximately 22 months ]
      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.


    Original Secondary Outcome: Same as current

    Information By: Xian-Janssen Pharmaceutical Ltd.

    Dates:
    Date Received: February 10, 2017
    Date Started: April 14, 2017
    Date Completion: December 31, 2018
    Last Updated: April 14, 2017
    Last Verified: April 2017