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

Conditions

• Chronic Phase-Chronic Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bosutinib 400 MG Monotherapy — DRUG
  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
• Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection — DRUG
  12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles

Study Details

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.

Key Dates

Start date

Feb 24, 2021

Status verified

Feb 2024

Primary completion

Sep 24, 2021

Completion

Sep 24, 2021

Study Design

Enrollment

9 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bosutinib-Atezolizumab Combination
  Drugs to be administered: Bosutinib 400 milligram (mg)/day Oral Tablet \[Bosulif 100mg oral tablets\] for 1 year Atezolizumab 1680 mg/28 days \[Tecentriq 840 MG in 14 ML Injection\] for 1 year

Primary Outcome Measure

Safety Profile of Bosutinib 400 mg Daily in Combination With Atezolizumab in Participants With Chronic Myeloid Leukemia as First Line Treatments [ Time Frame: through study completion, up to 7 months ]