OncoMatch/Clinical Trials/NCT05004064
Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma
Is NCT05004064 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT05004064 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.
Does this trial require CCND1?
Yes, CCND1 overexpression is a required biomarker for enrollment.
Does this trial require IGH?
Yes, IGH t(11;14)(q13;q32) is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages