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Trial Title:
Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma
NCT ID:
NCT05486013
Condition:
Mantle Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
30 patients with recurrent refractory mantle cell lymphoma.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100083
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Jing, Professor
Phone:
+861082265571
Email:
hongmeijing@bjmu.edu.cn
Start date:
May 26, 2022
Completion date:
November 26, 2025
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Hospital
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Tsinghua Changgeng Hospital
Agency class:
Other
Collaborator:
Agency:
China-Japan Friendship Hospital
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05486013