NCT04127916

Brief Summary

This study with retrospective data collection does not entail sample size calculation. The study will involve patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma and meet the inclusion/exclusion criteria at each participating study site. Considering the incidence of mantle cell lymphoma in Korea and the number of participating sites, the expected sample size is approximately 40.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

October 13, 2019

Last Update Submit

March 16, 2020

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate,

    Overall response rate, including complete response and partial response

    2020.12.30

Secondary Outcomes (5)

  • Progression-free survival

    2020.12.30

  • Overall survival

    2020.12.30

  • Duration of response

    2020.12.30

  • Treatment-emergent adverse event

    2020.12.30

  • Prognostic factor

    2020.12.30

Interventions

BendamustineDRUG

To investigate the efficacy and safety of bendamustine plus rituximab in patients with mantle cell lymphoma.

Also known as: Rituximab

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study with retrospective data collection does not entail sample size calculation. The study will involve patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma and meet the inclusion/exclusion criteria at each participating study site. Considering the incidence of mantle cell lymphoma in Korea and the number of participating sites, the expected sample size is approximately 40.

You may qualify if:

  • \. Patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the WHO classification)
  • mantle cell lymphoma
  • leukemic non-nodal mantle cell lymphoma
  • in situ mantle cell neoplasia 2. Age ≥ 19 years 3. Patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included.

You may not qualify if:

  • \. Patients whose clinical and pathological data are not available 2. Patients who were not treated with a combination of bendamustine and rituximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, 06351, South Korea

RECRUITING

Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, 06351, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Bendamustine HydrochlorideRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Kim wonseog, Professor

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim wonseog, Professor

CONTACT

010-9933-5823wonseog.kim@samsung.com

Kim seokjin

CONTACT

010-9933-1766seokjin88.kim@samsung.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,phD,Division of hematology, Department of medicine

Study Record Dates

First Submitted

October 13, 2019

First Posted

October 16, 2019

Study Start

January 30, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

There is no IPD sharing plan

Locations

KR(2)