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NCT05024045
B-cell Lymphoma, Blood Protein Disorders
Tucson, Arizona, United States
View Trial DetailsNCT Number: NCT03053024
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.
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Notify Me18 year and older
All sexes
Observational
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Continuous variable (age) will be summarized using descriptive statistics.
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.
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.
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 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: Baseline
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).
Time frame: Baseline
Categorical variable (gender) will be summarized using a frequency distribution with the number and percentage of participants in each category.
Time frame: Up to Follow-up (approximately 22 months)
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.
Time frame: Up to Follow-up (approximately 22 months)
The cumulated dose will be summarized using descriptive statistics.
Time frame: Up to Follow-up (approximately 22 months)
The frequency of BTZ will be summarized using a frequency distribution with the number and percentage of participants in each category.
Time frame: Up to Follow-up (approximately 22 months)
The reason of BTZ initiation/discontinuation/dose adjustment will be described with respective number of occurrence.
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.
Time frame: Approximately 22 months
The percentage of participants with CR and CRu in all participants whose treatment response data are available.
Time frame: Approximately 22 months
The percentage of participants with PR in all participants whose treatment response data are available.
Time frame: Approximately 22 months
Interval between start of treatment to the first day when CR/CRu or PR was observed.
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.
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.
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.
Xian-Janssen Pharmaceutical Ltd.
Industry
An Observational Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in China
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