Clinical trial NCT05506410: A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
Official title: A Prospective Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Newly Diagnosed Mantle Cell Lymphoma
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A newly diagnosed patient with mantle cell lymphoma

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.

Primary outcomes:
measure: progression free survival（PFS）
timeFrame: two years
Secondary outcomes:
measure: ORR
timeFrame: two years
measure: CRR
timeFrame: two years
measure: OS
timeFrame: two years
measure: ADR
timeFrame: two years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Oncology, The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Zhang Mingzhi Zhang
role: PRINCIPAL_INVESTIGATOR
References: