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Clinical Trials in China / NCT07719556
Recruiting Phase 2

Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL)

NCT07719556 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 2
Started
2026-07-15
Last updated
2026-07-22

Condition(s) studied

Mantle Cell Lymphoma (MCL)

Investigational drug(s) / intervention(s)

Orelabrutinib →Obinutuzumab →Venetoclax →

Orelabrutinib: Orelabrutinib: 150 mg, d1-d28, C1-C6 (Induction Phase ) ; 150 mg, d1-d28, C7-C24 (Maintenance Phase)

Obinutuzumab: Obinutuzumab: 1000 mg/m², on d1, d8, and d15 in C1; and on d1 in C2-C6 (Induction Phase ) ; 1000 mg/m², d1, once every 2 cycles, C7-C24 (Maintenance Phase)

Venetoclax: Venetoclax: dose ramp-up in C2 (20 mg → 400 mg); 400 mg on d1-d14 in C3-C6(Induction Phase ) ; 400 mg, d1-d14, C7-C24(Maintenance Phase)

Study summary

This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form; 2. Age ≥ 18 years, male or female; 3. Life expectancy ≥ 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients with ECOG 3 may be enrolled only if the decline in performance status is attributed to the underlying disease and the investigator determines that they may benefit from the treatment; 5. Pathologically confirmed diagnosis of mantle cell lymphoma (MCL) and treatment-naïve; 6. Presence of measurable and/or evaluable lymphoma lesions; 7. Adequate bone marrow reserve, defined as: absolute neutrophil count \> 1.0×10⁹/L or platelet count \> 75×10⁹/L, unless cytopenias are considered to be related to bone marrow involvement by lymphoma and deemed recoverable by the investigator; 8. Hepatic function: AST (SGOT) and ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN) (in the absence of liver involvement) or ≤ 5 × ULN (in the presence of liver involvement); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN; 9. Creatinine clearance ≥ 30 mL/min, calculated using the Cockcroft-Gault formula; 10. Able to comply with the study visit schedule and other protocol requirements; 11. All patients of childbearing potential must agree to use effective contraceptive measures during the study and for 24 months after study treatment discontinuation. Female patients of childbearing potential must have a negative urine pregnancy test prior to the first dose of study treatment. Exclusion Criteria: 1. Received prior treatment for lymphoma within 2 weeks before study enrollment; 2. Any serious medical condition, including but not limited to: * Uncontrolled hypertension (defined as blood pressure that remains uncontrolled after at least 4 weeks of treatment with a reasonable and tolerable regimen of 3 or more antihypertensive agents \[including diuretics\] at adequate doses, or requiring 4 or more antihypertensive agents to achieve adequate control); * Uncontrolled congestive heart failure within 6 months prior to screening (New York Heart Association \[NYHA\] Class III \[moderate\] or Class IV \[severe\] cardiac disease); * Left ventricular ejection fraction (LVEF) \< 50%; * Symptomatic coronary artery disease (e.g., chest tightness, chest pain, palpitations, fatigue) or coronary artery disease requiring medical therapy; ⑤Severe bradycardia (heart rate \< 40 beats per minute \[bpm\]) with hypotension, dizziness, or syncope; patients with a history of arrhythmia should undergo cardiac evaluation; * Known active bacterial, viral, fungal, or other infection (excluding fungal infection of the nail bed), or major infection within 2 weeks prior to the first dose of study drug; * Moderate to severe hepatic impairment (Child-Pugh Class B or C); ⑧Active bleeding within 2 months prior to screening, or clear evidence of bleeding diathesis as judged by the investigator; ⑨Current pulmonary disease that impairs lung function, such as pulmonary fibrosis or drug-related pneumonitis, which is deemed intolerable by the investigator; ⑩Any psychiatric or cognitive disorder that may limit the patient's ability to understand, execute, or comply with the informed consent and study requirements; 3. Known active hepatitis C virus (HCV) infection; or other acquired or congenital immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) infection; 4. All patients with central nervous system (CNS) involvement by lymphoma; 5. Diagnosis of or receiving treatment for another malignancy other than lymphoma, except for the following: ①Malignancy that has been treated with curative intent and with no known active disease for ≥ 5 years prior to enrollment; ②Adequately treated basal cell carcinoma of the skin (excluding melanoma) with no evidence of disease; ③Adequately treated carcinoma in situ of the cervix with no evidence of disease; 6. Known hypersensitivity to any study drug; 7. Pregnant or breastfeeding women; 8. History of stroke or intracranial hemorrhage within 6 months prior to enrollment; 9. Requirement for anticoagulation therapy with warfarin or equivalent vitamin K antagonists; 10. Requirement for long-term treatment with strong cytochrome P450 3A (CYP3A) inhibitors; 11. Receipt of live attenuated vaccine within 4 weeks prior to enrollment.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Changzhou Second People's Hospital Changzhou Jiangsu Recruiting
Jiangsu province Hospital Nanjing Jiangsu Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More The First Affiliated Hospital with Nanjing Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07719556 on ClinicalTrials.gov ↗ ← All trials in China