Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma

NCT05486013 | Unknown DMC

• 1 other identifier: M2022276
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• The objective response rate

  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 Outcomes (1)

• The negative rate of minimal residual disease

  From the first day of medication to the end of 1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients with recurrent refractory mantle cell lymphoma.

You may qualify if:

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

You may not qualify if:

• Patients who have been enrolled in other clinical trials.
• Patients who are receiving immunosuppressive therapy for other diseases.
• Patients who have received other treatments for lymphoma before joining the group.
• Complicated with other malignant tumors.
• The researchers determined that the patients were not suitable for the study.
• Severe mental or neurological disorders that affect informed consent or expression of adverse reactions.
• Patients who cannot 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 trial.
• 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.
• Incomplete research data records.
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hongmei T Jing, Ph.D

CONTACT

+861082265571; hongmeijing@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 4, 2022
• First Posted: August 3, 2022
• Study Start: May 26, 2022
• Primary Completion: May 26, 2025
• Study Completion: November 26, 2025
• Last Updated: August 3, 2022

Record last verified: 2022-06

Locations

CN (1)