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Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients

NCT04793399 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-03-19

Study results available
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Summary

The combination of bosutinib plus atezolizumab in first line treatment in newly diagnosis chronic-phase Chronic Myeloid Leukemia (CML) patients could potentially increase molecular responses and therefore treatment discontinuation probabilities in these patients. We propose an Open-Label Phase Ib/II Study of Bosutinib in Combination with Atezolizumab for the Treatment of New Diagnosis Chronic Phase-Chronic Myeloid Leukemia Patients.

Conditions

  • Chronic Phase-Chronic Myeloid Leukemia

Interventions

DRUG

Bosutinib 400 MG Monotherapy

One cycle (28 days) only with bosutinib 400 mg/day therapy at the beginning of the trial + 12 cycles with bosutinib 400 mg/day therapy after combined therapy

DRUG

Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection

12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Roche Farma, S.A

    collaborator INDUSTRY

  • Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica

    lead OTHER

Principal Investigators

  • Valentin Garcia, Dr. · Hospital Ramon y Cajal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2021-09-24
Completion
2021-09-24

Countries

  • Spain

Study Locations

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Entities

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 NCT04793399 on ClinicalTrials.gov