Phase II Study of Blinatumomab and Asciminib for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06308588

Provider View

This clinical trial is testing whether a combination of two drugs, blinatumomab and asciminib, can help control a type of leukemia called Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL).

Patient Parameters

Program Overview

The study aims to find out if combining the drugs blinatumomab and asciminib can effectively manage Ph+ ALL. It will also look at how well this combination works in patients who are newly diagnosed or have relapsed or resistant forms of the disease.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of asciminib when used with blinatumomab. In Phase II, they will evaluate how well the treatment works in reducing measurable residual disease (MRD) in newly diagnosed patients and the overall response in those with relapsed or resistant disease.

Secondary goals include assessing other treatment outcomes like complete molecular response, relapse-free survival, and overall survival. The study will also monitor the safety of the drug combination.

Exploratory goals involve understanding how certain genetic mutations might affect treatment success and comparing different methods of measuring MRD. Researchers will also study how the treatment affects different types of immune cells.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with newly diagnosed or minimally treated Ph+ ALL who are not suitable for intensive chemotherapy.
  • Adults aged 18 or older with relapsed or resistant Ph+ ALL or previously treated lymphoid blast phase CML.
  • Good overall health with a performance status of 2 or less on the ECOG scale.
  • Adequate liver function, with specific limits on liver enzyme levels unless related to leukemia.
  • Adequate kidney function with a creatinine clearance of at least 30 mL/min.
  • Adequate pancreatic function with specific limits on enzyme levels.
  • Adequate heart function based on medical history and physical exam.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Ability to understand and willingness to sign informed consent.

Exclusion Criteria

  • Active serious infections not controlled by antibiotics.
  • Another active cancer that could shorten life expectancy to less than a year, except for certain skin cancers.
  • Severe heart failure as defined by specific medical criteria.
  • Prolonged QTc interval on an ECG unless corrected or approved by a cardiologist.
  • History of significant brain or nervous system disorders, except for active CNS leukemia.
  • Recent treatment with investigational or chemotherapy agents unless fully recovered or in life-threatening situations.
  • Pregnant or breastfeeding women are not eligible. Women of childbearing potential must have a negative pregnancy test and agree to use contraception. Men must understand the risks to partners and use effective birth control.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.