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Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma

NCT05820841 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2023-08-31

No results posted yet for this study

Summary

The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib.

Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.

Conditions

Interventions

DRUG

R-miniCHOP + Acalabrutinib

* Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5) * Acalabrutinib 100 mg p.o. twice daily starting from D1 of first R-miniCHOP cycle continuously to D21 of cycle 8. Cycles repeated every 3 weeks

DRUG

R-miniCHOP

* Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5). Cycles repeated every 3 weeks

Sponsors & Collaborators

  • University of Leipzig

    collaborator OTHER

  • University Hospital Regensburg

    collaborator OTHER

  • Wuerzburg University Hospital

    collaborator OTHER

  • University Hospital of Gießen and Marburg

    collaborator UNKNOWN

  • Saarland University Medical Center

    collaborator UNKNOWN

  • AstraZeneca

    collaborator INDUSTRY

  • Universität des Saarlandes

    lead OTHER

Principal Investigators

  • Konstantinos Christofyllakis, MD MSc · Saarland University Medical Center

  • Moritz Bewarder, MD, PD · Saarland University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2028-04-30
Completion
2028-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05820841 on ClinicalTrials.gov