Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma

August 1, 2022 updated by: Peking University Third Hospital

A Prospective, Open, Multicenter Clinical Observational Study of Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma

80% of patients with mantle cell lymphoma (mantle cell lymphoma, MCL)were in the advanced tumor stage when they were first diagnosed. Zabutinib, as a new generation of BTK inhibitors, has better targeting and safety in clinical application. Previous studies have confirmed that zabutinib has good efficacy in treating relapsed refractory MCL. However, for patients with a high risk of drug resistance to BTK inhibitors or patients with drug resistance, the efficacy of BTK inhibitors alone is poor, and combined therapy can improve the poor prognosis of these patients. Therefore, the primary purpose of this study is to evaluate the safety and efficacy of zebutenil in treating recurrent, refractory mantle cell lymphoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Mantle cell lymphoma (mantle cell lymphoma, MCL) is a kind of B-cell lymphoma with unique histomorphology, immunophenotype, and cytogenetic characteristics, accounting for 6% of non-Hodgkin's lymphoma. It usually occurs in older adults, with a median age of 68. In recent years, although the application of new drugs has made much progress in the treatment of mantle cell lymphoma, the overall curative effect is not good. The vast majority of patients relapse after treatment. The median survival time is 3-5 years due to a lack of standard treatment. MCL responds to combined therapy, but easy recurrence is still problematic in clinical treatment. 50% to 60% of MCL eventually relapsed after treatment. Among them, BTK inhibitors exert their anti-tumor activity by promoting apoptosis and inhibiting tumor cell proliferation, inhibiting chemokine from blocking B cell migration, and reducing tumor B cell adhesion, which has become a milestone in the treatment of recurrent, refractory MCL. Zabutinib, as a second-generation BTK inhibitor, optimizes its chemical structure. Compared with the first-generation BTK inhibitor, zabutinib has complete and lasting BTK inhibition, more accurate targeting selection, and better clinical application safety. Previous clinical studies have shown that BTK inhibitor zabutinib is effective in treating recurrent and refractory MCL. However, using BTK inhibitors alone to produce drug resistance will cause rapid tumor growth in MCL patients, which has always been a difficulty in clinical treatment. A retrospective analysis of 693 Chinese patients with MCL showed that the complete remission rate (CR） of the initial treatment of MCL in China was 40.9%, the objective remission rate（ORR） was 81.6%, the 5-year progression-free survival rate(PFS) was 51.2%, and the 5-year overall survival time (OS) was 58.4%. It is significantly lower than the curative effect on foreign patients. At the same time, 56.8% of the patients relapsed after remission, so the treatment plan for patients in the Chinese population needs to be further optimized. Currently, the clinical application of zabutinib combined with ortozumab, a BCL-2 inhibitor, dexamethasone, and pomalidomide is one of the therapeutic regimens for recurrent refractory MCL with a high complete remission rate and safety. In order to better collect the clinical data on zabutinib combination therapy and make a more scientific and accurate evaluation, this study carried out a clinical observation study on the safety and efficacy of zabutinib combination therapy in recurrent refractory MCL. The survival index was evaluated by the objective remission rate (ORR) of 2 and 4 cycles of the combination regimen, and the adverse reactions and recurrence rates were collected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100083
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 patients with recurrent refractory mantle cell lymphoma.

Description

Inclusion Criteria:

  1. Patients who have been enrolled in other clinical trials.
  2. Patients who are receiving immunosuppressive therapy for other diseases.
  3. Patients who have received other treatments for lymphoma before joining the group.
  4. Complicated with other malignant tumors.
  5. The researchers determined that the patients were not suitable for the study.
  6. Severe mental or neurological disorders that affect informed consent or expression of adverse reactions.
  7. Patients who cannot be followed up.

Exclusion Criteria:

  1. Patients who have been enrolled in other clinical trials.
  2. Patients who are receiving immunosuppressive therapy for other diseases.
  3. Patients who have received other treatments for lymphoma before joining the group.
  4. Complicated with other malignant tumors.
  5. The researchers determined that the patients were not suitable for the study.
  6. Severe mental or neurological disorders that affect informed consent or expression of adverse reactions.
  7. Patients who cannot be followed up.

Exit (drop-off) criteria :

  1. Subject requires to quit.
  2. Serious adverse events occurred during the trial, so it is inappropriate to continue the trial.
  3. Due to the progression of the disease during the trial, it is not appropriate to continue to use the trial drugs and / or to continue this study program.
  4. Incomplete research data records.
  5. Patients who cannot be followed up.

Withdrawal cases should be retained for future reference and transferred from the last record to the final record for ITT analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The objective response rate
Time Frame: From the time of the first drug administration until the end of two cycles (each cycle is 28 days)
This trial's primary outcome is the objective response rate (ORR) of two cycles of treatment
From the time of the first drug administration until the end of two cycles (each cycle is 28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The negative rate of minimal residual disease
Time Frame: From the first day of medication to the end of 1 year
The secondary outcome of this trial is 1-year negative rate of minimal residual disease(MRD)
From the first day of medication to the end of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking Union Medical College Hospital
Chinese PLA General Hospital
Beijing Hospital
China-Japan Friendship Hospital
Beijing Tsinghua Changgeng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2022276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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