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NCT04546620ACTIVE_NOT_RECRUITINGanonymous

A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib

Sponsor

Source record

University Hospital Southampton NHS Foundation Trust

Phase

Source record

PHASE2

Modality

AI-normalized

small molecule

Target

AI-normalized

R-CHOP, R-CHOP + acalabrutinib

Indication / condition

AI-normalized

Diffuse Large B Cell Lymphoma

Intervention

Source record

R-CHOP, R-CHOP + acalabrutinib

Source & freshness

Source record

NCT ID

NCT04546620

Original source

ClinicalTrials.gov

Source last updated

Apr 30, 2026

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT04546620

Title

A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib

Sponsor

University Hospital Southampton NHS Foundation Trust

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE2

Condition raw

Diffuse Large B Cell Lymphoma

Condition normalized

Diffuse Large B Cell Lymphoma

Modality raw

small molecule

Modality normalized

small molecule

Target raw

R-CHOP, R-CHOP + acalabrutinib

Target normalized

R-CHOP, R-CHOP + acalabrutinib

Interventions

R-CHOP, R-CHOP + acalabrutinib

Public preview

Source record

This study evaluates the addition of Acalabrutinib to current standard therapy of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (R-CHOP) for patients with previously untreated CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) requiring full course chemoimmunotherapy.

All patients will receive one cycle of R-CHOP. Two thirds of patients (Arm B) will go on to receive a further 5 cycles (every 21 days) of R-CHOP with Acalabrutinib. Acalabrutinib will be taken orally twice daily continuously in 21 day cycles.

One third of patients (Arm A) will continue with 5 cycles of R-CHOP.

Patients will be followed up initially for 24 months and then for disease status and survival until 114 progression events have been observed.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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