OncoMatch/Clinical Trials/NCT05004064
Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma
Is NCT05004064 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Acalabrutinib and Rituximab for mantle cell lymphoma.
Treatment: Acalabrutinib · Rituximab — This is a phase II, single-arm, open-label, multicentre study of acalabrutinib and rituximab for elderly or frail patients with previously untreated mantle cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
overexpress cyclin D1
Required: IGH t(11;14)(q13;q32)
chromosome translocation t(11;14)(q13;q32)
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: any therapy for MCL
Exception: prior localised radiotherapy, a 10-day pulse of high dose steroids or continuous prednisolone above 20mg od or equivalent for symptom control
Any prior therapy (including targeted inhibitors) for MCL (other than prior localised radiotherapy, a 10-day pulse of high dose steroids or continuous prednisolone above 20mg od or equivalent for symptom control)
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0 x 10^9/L (unless related to bone marrow infiltration or splenomegaly due to underlying MCL, where platelets between 50-75 x10^9/L are acceptable); platelets ≥75 x10^9/L unless related to bone marrow infiltration or splenomegaly due to underlying MCL (where platelets between 50-75 x10^9/L are acceptable)
Kidney function
Calculated creatinine clearance ≥ 30 mL/min.
Liver function
Total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's syndrome or of non-hepatic origin. AST and/or ALT ≤ 3 x ULN.
Cardiac function
No clinically significant cardiovascular disease such as uncontrolled arrhythmias, myocardial infarction within 6 months, or any Class 3 or 4 cardiac disease as defined by NYHA, or QTc > 480 msec at screening. LVEF ≤ 50% as assessed by echocardiogram (inclusion for specific subgroups).
Total bilirubin > 1.5 x ULN, unless due to Gilbert's syndrome or of non-hepatic origin. AST and/or ALT > 3 x ULN. Calculated creatinine clearance <30 mL/min. Absolute neutrophil count <1.0 x 10^9/L (or requires growth factor support to maintain absolute neutrophil count >1.0 x 10^9/L) and/or platelets <75 x10^9/L unless related to bone marrow infiltration or splenomegaly due to underlying MCL (where platelets between 50-75 x10^9/L are acceptable). Clinically significant cardiovascular disease such as uncontrolled arrhythmias, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification (33), or corrected QT interval (QTc) > 480 msec at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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