A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma

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

Study Overview

• Status: Recruiting
• Conditions: Newly Diagnosed Mantle Cell Lymphoma
• Intervention / Treatment: Drug: Rituximab

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Zhang Mingzhi Zhang, Doctor; Phone Number: 13838565629; Email: Mingzhi_zhang@126.com
• Study Contact Backup: Name: Zhang Lei Zhang, Doctor; Phone Number: 13525533696

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Department of Oncology, The First Affiliated Hospital of Zhengzhou University
      • Contact: Zhang Lei Zhang; Phone Number: 13525533696

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A newly diagnosed patient with mantle cell lymphoma

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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)

Drug: Rituximab; 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).; Other Names: Cytarabine; Prednisone; Bendamustine; BTK inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival（PFS）	progression free survival	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	objective remission rate	two years
CRR	complete remission rate	two years
OS	overall survival	two years
ADR	adverse drug reaction	two years

Collaborators and Investigators

• Sponsor: Zhengzhou University
• Investigators: Principal Investigator: Zhang Mingzhi Zhang, The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2022
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): December 30, 2026

Study Registration Dates

• First Submitted: August 13, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (ACTUAL): August 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Mantle-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Immunological; Bendamustine Hydrochloride; Rituximab; Prednisone; Cytarabine
• Other Study ID Numbers: hnslblzlzx20220812

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No