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Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas

NCT05583149 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-01-29

Study results available
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Summary

This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma.

This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce

Conditions

  • Refractory Aggressive B-cell Lymphomas
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Aggressive B-cell NHL
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • De Novo or Transformed Indolent B-cell Lymphoma
  • DLBCL, Nos Genetic Subtypes
  • T Cell/Histiocyte-rich Large B-cell Lymphoma
  • EBV-Positive DLBCL, Nos
  • Primary Mediastinal [Thymic] Large B-cell Lymphoma (PMBCL)
  • High-Grade B-Cell Lymphoma, Nos
  • C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma
  • Grade 3b Follicular Lymphoma
  • C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma

Interventions

DRUG

ACALABRUTINIB

Oral, twice daily, timing and dosage per protocol

DRUG

LISOCABTAGENE MARALEUCEL

via IV timings and dosage per protocol

DRUG

Lymphodepleting chemotherapy

lymphodepleting chemotherapy with cyclophosphamide and fludarabine once a day for 3 days via IV about 2-4 hours. This will occur only once prior to lisocabtagene maraleucel infusion.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Patrick C. Johnson, MD

    lead OTHER

Principal Investigators

  • Connor Johnson, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-11-23
Completion
2029-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT05583149 on ClinicalTrials.gov