NCT04061850

Brief Summary

To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

August 14, 2019

Last Update Submit

October 21, 2020

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival period

    Progression free survival period with ibrutinib

    Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date

Secondary Outcomes (1)

  • Overall response rate

    Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Aged ≥ 19 years, relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation

You may qualify if:

  • Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)
  • mantle cell lymphoma
  • leukemic nonnodal mantle cell lymphoma
  • in situ mantle cell neoplasia
  • Aged ≥ 19 years
  • Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation

You may not qualify if:

  • Patients whose clinical and pathological data are not available
  • Patients who were not treated with ibrutinib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • Won Seog Kim, Professor

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D, Professor of Hematology-Oncology

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 20, 2019

Study Start

July 1, 2019

Primary Completion

March 31, 2020

Study Completion

August 31, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

KR(1)