NCT05506410 A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
| NCT ID | NCT05506410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhengzhou University |
| Condition | Newly Diagnosed Mantle Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-12 |
| Primary Completion | 2024-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-08-12 with a primary completion date of 2024-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma
Eligibility Criteria
Inclusion Criteria: 1. Age 18-70, ECOG score 0-2; 2. Estimated survival time \>6 months; 3. Mantle cell lymphoma was confirmed by pathology. 4. 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); 5. 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; 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); Exclusion Criteria: 1. 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; 2. Participating in other clinical trials or participating in other clinical investigators 4 weeks before enrollment (except those not receiving treatment); 3. Systemic autoimmune disease or immune deficiency; 4. Refusing to collect blood samples; 5. Allergic to any drug in the protocol; 6. Pregnant and lactating women; 7. Major diseases that can cause test interference and uncontrolled active infected persons; 8. Primary or secondary central tumor; 9. Contraindications to chemotherapy; 10. Not considered suitable for inclusion. 11. 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.
Contact & Investigator
Zhang Mingzhi Zhang
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Frequently Asked Questions
Who can join the NCT05506410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Newly Diagnosed Mantle Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05506410 currently recruiting?
Yes, NCT05506410 is actively recruiting participants. Contact the research team at Mingzhi_zhang@126.com for enrollment information.
Where is the NCT05506410 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT05506410 clinical trial?
NCT05506410 is sponsored by Zhengzhou University. The principal investigator is Zhang Mingzhi Zhang at The First Affiliated Hospital of Zhengzhou University. The trial plans to enroll 100 participants.