Blinatumomab + Asciminib for Philadelphia Chromosome Positive Leukemia

Phase 2

Recruiting

Led By Nicholas Short, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking to see if using both blinatumomab and asciminib together can help manage Ph+ ALL."

Who is the study for?

This trial is for patients with a type of leukemia known as Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have tried other treatments first.

What is being tested?

The study is testing the effectiveness of combining two drugs, Blinatumomab and Asciminib, in treating Ph+ ALL. It's a Phase II trial, which means it focuses on the treatment's efficacy and side effects in a larger group than initial trials.

What are the potential side effects?

While specific side effects are not listed here, common ones for cancer treatments like Blinatumomab and Asciminib can include fatigue, fever, bleeding or bruising easily due to low blood cell counts, nausea or vomiting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Blinatumomab + AsciminibExperimental Treatment2 Interventions

Participants found to be eligible to take part in this study will receive 5 cycles of blinatumomab and asciminib, followed by asciminib alone for as long as it benefits the participant. Participants will receive blinatumomab as a continuous (non-stop) infusion on Days 4-31 of Cycle 1 and on Days 1-28 of Cycles 2-5. Participants will take asciminib by mouth 2 times every day during this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asciminib

2018

Completed Phase 1

~570

Blinatumomab

2014

Completed Phase 3

~1230