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A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL

NCT05950997 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2024-05-09

No results posted yet for this study

Summary

This is a single-arm, prospective study to assess the efficacy and safety of acalabrutinib combined with obinutuzumab in subjects with previously untreated chronic lymphocytic leukemia.

Conditions

Interventions

DRUG

Acalabrutinib

100 mg capsules administered by mouth once daily (28-day cycles)

DRUG

Obinutuzumab

100 mg administered intravenously on Day 1 and 900 mg administered intravenously on Day 2, 1000 mg administered intravenously on Day 8 and 15 of cycle 2 and 1000 mg on Day 1 of subsequent cycles for a total of 6 cycles (28-day cycles)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Jianyong Li, PhD, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2026-05-31
Completion
2026-09-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT05950997 on ClinicalTrials.gov