Actively Recruiting
A Prospective Clinical Study of Hanlikang and BTK Inhibitors in Newly Diagnosed Mantle Cell Lymphoma
Led by Zhengzhou University · Updated on 2022-08-18
100
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Hanlikang and BTK inhibitors in treating patients newly diagnosed with mantle cell lymphoma. This clinical study is open-label, single-arm, and conducted at multiple centers to observe treatment effects and safety in this patient group. The study aims to evaluate progression-free survival over two years among other important outcomes. The treatment involves combining Rituximab, Bendamustine, Cytarabine, and Prednisone (referred to as R-BAP) with BTK inhibitors. Younger patients under 65 receive six cycles of R-BAP with oral ibrutinib during chemotherapy and continue ibrutinib for one year after. Patients 65 and older receive four cycles of R-BAP, followed by four cycles of rituximab consolidation and one year of oral zanubrutinib. Treatment responses and side effects are regularly assessed. Participants will undergo regular evaluations including efficacy assessments every two cycles during chemotherapy and every three months during the BTK inhibitor maintenance phase. Researchers will monitor progression-free survival, response rates, overall survival, and adverse reactions over two years. The study requires participants to cooperate with follow-up visits and use contraception if of childbearing potential. Total participation duration aligns with treatment and follow-up timelines.
CONDITIONS
Brief Title
A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years with ECOG score 0 to 2
- Estimated survival time longer than 6 months
- Mantle cell lymphoma confirmed by pathology
- Acceptable blood counts without chemotherapy contraindications: neutrophils ≥1.0 x 10^9/L, platelets ≥75 x 10^9/L, hemoglobin ≥80 g/L (except for bone marrow infiltration cases)
- At least one measurable lesion: lymph node lesion with long diameter ≥1.5 cm and short diameter ≥1.0 cm; extranodal lesion length ≥1.0 cm
- Liver function within limits: total bilirubin ≤1.5 times upper limit of normal (ULN); ALT or AST ≤2.5 x ULN; alkaline phosphatase ≤3 x ULN if no bone invasion
- Kidney function within limits: serum creatinine ≤1.5 x ULN
- Normal heart function without other major diseases
- Willingness to use adequate contraception during study and negative pregnancy test within 7 days before first dose for women of childbearing age
- Voluntary participation with signed informed consent and willingness to comply with follow-up
- No other relevant anti-tumor treatments including traditional Chinese medicine, immunotherapy, or biologics (except for symptom relief)
You will not qualify if you...
- Definite neuropathy or psychosis, including dementia or seizures
- History of psychotropic substance abuse or inability to abstain
- Participation in other clinical trials within 4 weeks before enrollment (except untreated cases)
- Systemic autoimmune disease or immune deficiency
- Refusal to provide blood samples
- Allergy to any study drug
- Pregnant or breastfeeding women
- Major interfering diseases or uncontrolled active infections
- Primary or secondary central nervous system tumors
- Contraindications to chemotherapy
- Not suitable for inclusion as judged by investigators
- Active infections requiring intravenous antibiotics or hospitalization within 4 weeks prior
- Use of other anti-tumor therapies such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy
- Serious medical conditions limiting study participation such as uncontrolled diabetes, severe cardiac insufficiency, recent acute coronary syndrome or coronary procedures, severe arrhythmias, uncontrolled hypertension, gastric ulcers at risk of perforation, active autoimmune diseases, severe respiratory diseases
- Hemophagocytic cell syndrome
- Positive for hepatitis B, hepatitis C, HIV, CMV DNA, or syphilis infection outside normal reference ranges
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 cycles of chemotherapy plus 1 year of oral BTK inhibitor maintenance
Participants receive cycles of R-BAP chemotherapy combined with BTK inhibitors, followed by maintenance oral BTK inhibitor therapy.
Visits every 2 cycles during chemotherapy and every 3 months during maintenance
Trial Site Locations
Total: 1 location
1
Department of Oncology, The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
Z
Zhang Mingzhi Zhang, Doctor
Z
Zhang Lei Zhang, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Frequently Asked Questions
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