NCT05406154

Brief Summary

This study is a prospective observational clinical trial. A total of 19 research centers were involved in this study. Each site plans to enroll 2-3 patients, and a total of 60 patients will be enrolled. Patients who met the diagnosis of mantle cell lymphoma by histological examination, ECOG (Eastern Oncology Collaborative Group) score 0-2, age \>65 years, expected survival of more than 3 months, and at least one measurable lesion were included in this observational clinical trial. In this study, clinical data of patients treated with R-B regimen combined with ibrutinib will be collected, including routine clinical laboratory tests, examinations, and molecular biological data, for efficacy assessment and survival analysis. The main evaluation indicators are the total effective rate of 2 and 6 cycles of alternating R-CHOP/R-DHAP combined with ibrutinib in the treatment of newly treated muff cell lymphoma patients. The 3-year progression-free survival (PFS) and overall survival (OS) of the patients will be assessed, and adverse events to treatment will be collected to evaluate the safety of ibrutinib in combination with untreated mask cell lymphoma.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 30, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

July 8, 2021

Last Update Submit

May 31, 2022

Conditions

Mantle Cell Lymphoma (MCL)

Keywords

MCLIbrutinibaged > 65 years

Outcome Measures

Primary Outcomes (2)

  • the overall response (complete response + partial response)

    Objective response rate，sum of complete response rate and partial response rate of ibrutinib combination therapy in initial treatment of MCL

    From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)

  • the overall response (complete response + partial response)

    Objective response rate，sum of complete response rate and partial response rate of ibrutinib combination therapy in initial treatment of MCL

    From the date of first study drug administration until the end of Cycle 6 (each cycle is 28 days)

Secondary Outcomes (4)

  • Progression-free survival (PFS),OS,CR,DOR

    2 years

  • Incidence and severity of adverse events(AE)

    2 years

  • The recurrence rate of MCL after initial treatment with ibrutinib

    2 years

  • Minimal residual disease negative (MRD-) rate of patients combination therapy

    1 year and 2 years

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 patients with primary mantle cell lymphoma

You may qualify if:

  • Age \> 65 years old;
  • The pathological biopsy was consistent with mantle cell lymphoma;
  • Measurable lesions on cross-sectional imaging recorded by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) (defined as the presence of at least one two-dimensional measurable lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, regardless of the short axis diameter);
  • The physical status of the Eastern United States Cooperative Oncology Group (ECOG) ≤2 points;
  • Full liver function: upper limit of bilirubin≤3×normal value (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; Alkaline phosphatase (ALP) ≤5×ULN; Serum creatinine ≤1.5×ULN, or creatinine clearance rate calculated according to Cockcroft-Gault formula ≥35mL/min;
  • Voluntary participation, willingness to provide the above treatment data, signed and dated informed consent.

You may not qualify if:

  • Other clinical trials have been included;
  • Immunosuppressive therapy is being used for other diseases;
  • Lymphoma has been treated with other regimens before entry;
  • Complicated with other malignant tumors;
  • Those who are judged by the investigator to be unsuitable to participate in this study;
  • Serious mental or neurological disorder that affects informed consent and/or the presentation or observation of adverse reactions;
  • Patients who could not be followed up;
  • Exit (drop-off) criteria :
  • Subject requires to quit;
  • Serious adverse events occurred during the trial, so it is inappropriate to continue the clinical trial;
  • If the disease progresses during the study, it is inappropriate to continue using the experimental drug and/or cannot continue the study protocol;
  • Incomplete research data records;
  • Patients could not be followed up.Withdrawal cases should be retained for future reference and transferred from the last record to the final record for ITT analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

RECRUITING

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

  • Hongmei Jing, Professor

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Hongmei Jing, Professor

CONTACT

+86 01082265571hongmeijing@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

June 6, 2022

Study Start

December 30, 2020

Primary Completion

December 30, 2023

Study Completion

July 30, 2024

Last Updated

June 6, 2022

Record last verified: 2021-06

Locations

CN(1)