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OncoMatch/Clinical Trials/NCT07719556

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

Is NCT07719556 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Orelabrutinib and Obinutuzumab for mantle cell lymphoma (mcl).

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT07719556Data as of Sep 2026Location: China

Treatment: Orelabrutinib · Obinutuzumab · VenetoclaxThis 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Obinutuzumab

Targeted therapy

OrelabrutinibVenetoclax

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

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

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

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

Kidney function

serum creatinine (CRE) ≤ 1.5 × ULN; creatinine clearance ≥ 30 mL/min, calculated using the Cockcroft-Gault formula

Liver function

AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (in the absence of liver involvement) or ≤ 5 × ULN (in the presence of liver involvement); total bilirubin (TBIL) ≤ ULN

Cardiac function

Left ventricular ejection fraction (LVEF) < 50% [excluded]; uncontrolled congestive heart failure (NYHA Class III or IV); symptomatic coronary artery disease; severe bradycardia (heart rate < 40 bpm) with hypotension, dizziness, or syncope

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; Hepatic function: AST (SGOT) and ALT (SGPT) ≤ 2.5 × 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; Creatinine clearance ≥ 30 mL/min, calculated using the Cockcroft-Gault formula

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07719556 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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