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Lymphoma, Mantle-CellNCT03053024

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

An observational study of Lymphoma, Mantle-Cell, run by Xian-Janssen Pharmaceutical Ltd. at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Mantle-Cell
How many people
54 participants
Where
9 sitesChina
Study dates
14 Apr 2017to 30 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking University Cancer Hospital

    Beijing, 100142

  • The First Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital Central South University

    Changsha, 410008

  • Nanfang Hospital

    Guangzhou, 510515

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, 200025

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • Blood Disease Hospital of Chinese Academy of Medical Sciences

    Tianjin, 300020

Other trials in China

About this study

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

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.

Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03053024
Study groupRoleWhat they receive
Cohort 1: Relapse/refractory MCL (rrMCL ) ParticipantsParticipants 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 ParticipantsParticipants characteristics and treatment pattern of newly diagnosed MCL participants (if more than 20% of total BTZ-treated MCL) will be analysed for cohort 2.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographic Characteristic of Participants in Prospective Group: Age

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

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Up to Follow-up (approximately 22 months)

  5. 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).

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: Up to Follow-up (approximately 22 months)

  8. Treatment Pattern of Bortezomib (BTZ) Treated MCL participants: Dose

    The cumulated dose will be summarized using descriptive statistics.

    Measured: Up to Follow-up (approximately 22 months)

  9. 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.

    Measured: Up to Follow-up (approximately 22 months)

  10. 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.

    Measured: Up to Follow-up (approximately 22 months)

Secondary outcomes (7)

  1. 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.

    Measured: Approximately 22 months

  2. 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.

    Measured: Approximately 22 months

  3. Partial Remission (PR) Rate

    The percentage of participants with PR in all participants whose treatment response data are available.

    Measured: Approximately 22 months

  4. Time to Response (TTR)

    Interval between start of treatment to the first day when CR/CRu or PR was observed.

    Measured: Approximately 22 months

  5. 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.

    Measured: Approximately 22 months

  6. 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.

    Measured: Approximately 22 months

  7. 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.

    Measured: Approximately 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start14 Apr 2017
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053024
Sponsor's protocol ID
CR108287
Other IDs
26866138MCL4001
Status last verified
Nov 2020
First submitted
10 Feb 2017
Last updated
6 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Mantle-Cell, run by Xian-Janssen Pharmaceutical Ltd. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic Characteristic of Participants in Prospective Group: Age (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03053024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.

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