Actively Recruiting
A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
Led by Zhengzhou University · Updated on 2022-08-18
100
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-label, single-arm, multicenter, prospective clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma
CONDITIONS
Official 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 greater than 6 months
- Mantle cell lymphoma confirmed by pathology
- Acceptable blood counts without chemotherapy contraindications: neutrophils 1.0x10^9/L, platelets 75x10^9/L, hemoglobin 80g/L (except lymphoma with bone marrow infiltration)
- At least one measurable lesion: intranodal lesions with long diameter 1.5 cm and short diameter 1.0 cm; extranodal lesions length 1.0 cm
- Liver function within set limits: total bilirubin 1.5 x ULN; ALT or AST 2.5 x ULN; alkaline phosphatase 3 x ULN if no bone invasion
- Kidney function within set limits: serum creatinine 1.5 x ULN
- Normal heart function without other major diseases
- Willingness to use adequate contraception and negative pregnancy test for women of childbearing age
- Voluntary participation with signed informed consent and cooperation with follow-up
- No other relevant treatments such as anti-tumor traditional Chinese medicine, immunotherapy, or biologic therapy (except for symptom relief)
You will not qualify if you...
- Definite neuropathy, psychosis, dementia, seizures, psychotropic substance abuse, or other lesions increasing CNS toxicity
- Participation in other clinical trials or with other clinical investigators within 4 weeks before enrollment (except no treatment)
- Systemic autoimmune disease or immune deficiency
- Refusal to provide blood samples
- Allergy to any drug in the study protocol
- Pregnant or lactating women
- Major diseases causing test interference or uncontrolled active infections
- Primary or secondary central tumors
- Contraindications to chemotherapy
- Not suitable for inclusion according to investigators
- Active infections requiring intravenous antibiotics or hospitalization within 4 weeks before enrollment (except neoplastic fever)
- Use of other antitumor therapies such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy
- Serious medical conditions limiting participation, including uncontrolled diabetes, severe cardiac insufficiency (NYHA II or above), recent acute coronary syndrome or coronary revascularization, severe arrhythmias, uncontrolled hypertension, at-risk gastric ulcers, active autoimmune diseases, severe respiratory diseases
- Hemophagocytic cell syndrome
- Positive tests for hepatitis B or C, HIV, CMV DNA, or syphilis with abnormal viral loads or active infection
AI-Screening
AI-Powered Screening
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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
CONTACT
Z
Zhang Lei Zhang, Doctor
CONTACT
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
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