Newly Diagnosed Mantle Cell LymphomaNCT05506410
A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
An observational study of Newly Diagnosed Mantle Cell Lymphoma, run by Zhengzhou University at 1 site in China.
Trial summary
An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Newly Diagnosed Mantle Cell Lymphoma
- What is being tested?
- Rituximab
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2022to 30 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A newly diagnosed patient with mantle cell lymphoma
Who may be able to join
- Age 18-70, ECOG score 0-2;
- Estimated survival time >6 months;
- Mantle cell lymphoma was confirmed by pathology.
- Acceptable hematological indexes without chemotherapy contraindications; Neutrophil absolute value ≥1.0×10^9 /L, PLT≥75×10^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
- At least one measurable lesion. For intrnodal lesions, they were defined as long diameter ≥1.5cm and short diameter ≥1.0cm; For r extranodal lesions, the length should be ≥1.0cm;
- 7. Liver function: TBIL≤1.5×ULN; ALT or AST ≤2.5 x ULN; Alkaline phosphatase ≤3×ULN in patients with non-bone invasion;
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- 8. Kidney function: serum creatinine ≤1.5×ULN;
- 9. Excluding other major diseases, the heart function is normal;
- 10 Women and men of childbearing age and their spouses are willing to use adequate contraception throughout the study period, and women of childbearing age must have a negative serum pregnancy test within 7 days before the first dose;
- 11 Subjects voluntarily participated in the clinical trial, signed the informed consent form, and cooperated with the follow-up;
- 12. There is no other relevant treatment including traditional Chinese medicine (anti-tumor), immunotherapy, biologic therapy (except anti-bone metastasis and other symptoms);
Who cannot join
- Patients with definite neuropathy or psychosis, including dementia or seizures, a history of psychotropic substance abuse and inability to abstinence, or other substantial lesions that may increase CNS toxicity;
- Participating in other clinical trials or participating in other clinical investigators 4 weeks before enrollment (except those not receiving treatment);
- Systemic autoimmune disease or immune deficiency;
- Refusing to collect blood samples;
- Allergic to any drug in the protocol;
- Pregnant and lactating women;
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- Major diseases that can cause test interference and uncontrolled active infected persons;
- Primary or secondary central tumor;
- Contraindications to chemotherapy;
- Not considered suitable for inclusion.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (other than nail bed skin fungal infections) or any major systemic infection event requiring intravenous antibiotic treatment or hospitalization (other than neoplastic fever) within 4 weeks prior to enrollment;
- 13. Application of other antitumor therapies (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
- 14. Other serious medical conditions that may limit the subject's participation in the study, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or above); Acute coronary syndrome in the last 6 months; Coronary revascularization such as stenting, cabG, and other cardiac and macrovascular procedures within the last 6 months; Severe arrhythmias include frequent ventricular premature, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure >150mmHg, diastolic blood pressure >100mmHg. Gastric ulcers (those identified by the investigators as being at risk for perforation); Active autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory diseases (e.g. obstructive pulmonary disease and history of bronchospasm), etc.;
- 15. Hemophagocytic cell syndrome;
- 16. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) was positive, and the peripheral blood hepatitis B virus (HBV) DNA titer was not within the normal reference range; Hepatitis C virus (HCV) antibody positive and HCV RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; Who tested positive for syphilis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhang Lei Zhang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Department of Oncology, The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Zhang Lei Zhang, 13525533696
About this study
Official title: A Prospective Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma
- Conditions
- Newly Diagnosed Mantle Cell Lymphoma
- Being tested
- Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Bendamustine, Cytarabine, Prednisone, BTK inhibitors
Young patients (< 65 years of age) were treated with R-BAP for 6 cycles (efficacy was assessed every 2 cycles, and adverse events were recorded), together with oral ibrutinib, followed by oral ibrutinib for 1 year after chemotherapy (efficacy was assessed every 3 months). Elderly patients (≥65 years of age) received 4 cycles of R-BAP (efficacy assessed every 2 cycles, and adverse reactions recorded), followed by 4 cycles of rituximab consolidation (efficacy assessed every 2 cycles) and 1 year of oral zanubrutinib (efficacy assessed every 3 months).
| Study group | Role | What they receive |
|---|---|---|
| Arms | Experimental:Rituximab、Bendamustine、Cytarabine、Prednisone （R-BAP） combined with BTK inhibitors To observe the efficacy and safety of R-BAP combined with BTK inhibitors in the treatment of newly-treated patients with mantle cell lymphoma (MCL) Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival（PFS）
progression free survival
Measured: two years
Secondary outcomes (4)
ORR
objective remission rate
Measured: two years
CRR
complete remission rate
Measured: two years
OS
overall survival
Measured: two years
ADR
adverse drug reaction
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start12 Aug 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingzhi Zhang, Zhengzhou University
- Investigators
- Zhang Mingzhi Zhang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506410
- Sponsor's protocol ID
- hnslblzlzx20220812
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05506410
- Acronym / sponsor ID
- hnslblzlzx20220812
- Conditions
- Newly Diagnosed Mantle Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arms | – | Drug: RituximabExperimental:Rituximab、Bendamustine、Cytarabine、Prednisone （R-BAP） combined with BTK inhibitors To observe the efficacy and safety of R-BAP combined with BTK inhibitors in the treatment of newly-treated patients with mantle cell lymphoma (MCL) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A newly diagnosed patient with mantle cell lymphoma
Key inclusion criteria (11 listed)
- Age 18-70, ECOG score 0-2;
- Estimated survival time >6 months;
- Mantle cell lymphoma was confirmed by pathology.
- Acceptable hematological indexes without chemotherapy contraindications; Neutrophil absolute value ≥1.0×10^9 /L, PLT≥75×10^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
- At least one measurable lesion. For intrnodal lesions, they were defined as long diameter ≥1.5cm and short diameter ≥1.0cm; For r extranodal lesions, the length should be ≥1.0cm;
Key exclusion criteria (15 listed)
- Patients with definite neuropathy or psychosis, including dementia or seizures, a history of psychotropic substance abuse and inability to abstinence, or other substantial lesions that may increase CNS toxicity;
- Participating in other clinical trials or participating in other clinical investigators 4 weeks before enrollment (except those not receiving treatment);
- Systemic autoimmune disease or immune deficiency;
- Refusing to collect blood samples;
- Allergic to any drug in the protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Bendamustine, Cytarabine, Prednisone, BTK inhibitorsYoung patients (< 65 years of age) were treated with R-BAP for 6 cycles (efficacy was assessed every 2 cycles, and adverse events were recorded), together with oral ibrutinib, followed by oral ibrutinib for 1 year after chemotherapy (efficacy was assessed every 3 months). Elderly patients (≥65 years of age) received 4 cycles of R-BAP (efficacy assessed every 2 cycles, and adverse reactions recorded), followed by 4 cycles of rituximab consolidation (efficacy assessed every 2 cycles) and 1 year of oral zanubrutinib (efficacy assessed every 3 months). | Drug | Arms |
Primary outcome
progression free survival（PFS）
Time frame: two years
progression free survival
4 secondary outcomes
ORR
Time frame: two years
CRR
Time frame: two years
OS
Time frame: two years
ADR
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
Related trials for Newly Diagnosed Mantle Cell Lymphoma
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A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
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Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Older Patients With Newly Diagnosed Mantle Cell Lymphoma
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Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhang Lei Zhang, Doctor contact
Zhang Mingzhi Zhang principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Mantle Cell Lymphoma, run by Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Mingzhi Zhang, Doctor (13838565629, Mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival（PFS） (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.