MedTrace Logo

Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL

NCT03736616 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-07-22

No results posted yet for this study

Summary

To evaluate the tolerability,feasibility, and efficacy of combining acalabrutinib with RICE chemotherapy as second line therapy in relapsed/refractory DLBCL patients with separate primary objectives in each of in two cohorts:

Cohort A: Hematopoeitic stem cell transplantation (HSCT) eligible patients undergoing second-line salvage chemoimmunotherapy \[Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE)\] plus acalabrutinib:.

Cohort B: Individuals not eligible for HSCT undergoing second-line salvage chemoimmunotherapy \[Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE)\] plus acalabrutinib followed by acalabrutinib as a maintenance therapy

Conditions

Interventions

DRUG

Carboplatin

Chemotherapy

DRUG

Ifosfamide

Chemotherapy

DRUG

Etoposide

Chemotherapy

BIOLOGICAL

Rituximab

Anti-CD20 mAb

DRUG

Carmustine

Chemotherapy

DRUG

Cytarabine

Chemotherapy

DRUG

Melphalan

Chemotherapy

OTHER

Autologous HSCT

Cellular Therapy

DRUG

Acalabrutinib

Bruton's Tyrosine Kinase Inhibitor

Sponsors & Collaborators

  • Acerta Pharma BV

    collaborator INDUSTRY

  • Swedish Medical Center

    lead OTHER

Principal Investigators

  • Krish Patel, MD · Swedish Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-16
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03736616 on ClinicalTrials.gov