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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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;

⁃ 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);

Locations
Other Locations
China
Department of Oncology, The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Zhang Mingzhi Zhang, Doctor
Mingzhi_zhang@126.com
13838565629
Backup
Zhang Lei Zhang, Doctor
13525533696
Time Frame
Start Date: 2022-08-12
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 100
Treatments
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)
Sponsors
Leads: Zhengzhou University

This content was sourced from clinicaltrials.gov