New treatment for relapsed or refractory precursor B-cell Acute Lymphoblastic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study investigates the safety and efficacy of a new treatment, MK-1045, for patients with precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that has either relapsed or is refractory to previous treatments. The study is divided into two phases: the first phase focuses on determining the optimal and safe dosage of MK-1045, while the second phase evaluates how effectively MK-1045 treats B-ALL. Participants include both adults and children aged 2 years and older who meet specific criteria related to their leukemia diagnosis and treatment history.

Why it matters

Who can join: the full rules

The main inclusion criteria include but are not limited to:

* Adult participants must be age 18 or older
* Pediatric participants must be at least 2 years old and less than 18 years old.
* Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment
* Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:

  * Failure to achieve complete remission after initial induction therapy;
  * Failure to achieve complete remission after salvage treatment;
  * Relapse with first remission duration ≤12 months
  * Second or later relapse
  * Relapse after allogeneic HSCT
* Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory/relapse criteria above or, those with the T315I mutation

The main exclusion criteria include but are not limited to:

* History of Burkitt's leukemia.
* Received anti-CD19 therapy within 3 months prior to entering the study
* Received allogeneic HSCT within 12 weeks prior to entering the study
* Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study
* History or presence of clinically relevant central nervous system (CNS) pathology
* Has CNS infiltration. Participants who had previous CNS infiltration, but it was controlled with intrathecal therapy are permitted to enroll.
* History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.
* History of serious cardiovascular and cerebrovascular disease
* Has active autoimmune diseases that may relapse

Where it's running

• The Second Affiliated Hospital of Third Military Medical University ( Site 0008)
  Chongqing, Chongqing Municipality, China Recruiting
• Southern Medical University Nanfang Hospital ( Site 0004)
  Guangzhou, Guangdong, China Recruiting
• The Second Hospital of Hebei Medical University ( Site 0003)
  Shijiazhuang, Hebei, China Recruiting
• The First Hospital of Harbin ( Site 0005)
  Harbin, Heilongjiang, China Recruiting
• Henan Cancer Hospital-hematology department ( Site 0002)
  Zhengzhou, Henan, China Recruiting
• Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010)
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Jianxiang Wang, Dr. — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.