Treatment for newly diagnosed Ph-positive acute lymphoblastic leukemia without chemotherapy

A Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of VAO Regimen in Patients With Newly Diagnosed Ph-positive Acute Lymphoblastic Leukemia

This study is testing a new treatment without chemotherapy for people who have just been diagnosed with a specific type of leukemia to see if it can help them feel better and improve their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy, Orebatinib
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06578546 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the safety and efficacy of a chemotherapy-free regimen consisting of Venetoclax, Azacitidine, and Orebatinib for patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-positive ALL). The study is designed as a single-arm, open-label, multicenter trial where participants will receive the treatment during the induction phase. Those who respond positively will have the option to undergo consolidation treatment and potentially an allogeneic hematopoietic stem cell transplantation, followed by maintenance therapy based on individual preferences.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed Ph-positive ALL who have not received prior chemotherapy or targeted therapy.

Not a fit: Patients with other malignant diseases, uncontrolled infections, or significant cardiovascular dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less toxic alternative to traditional chemotherapy for patients with Ph-positive ALL.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in targeting Ph-positive ALL with novel agents, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
2. Age ≥18.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-3.
4. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
5. Creatinine clearance ≥ 30 mL/min.
6. Serum lipase ≤ 1.5 x ULN, amylase =\< 1.5 x ULN.
7. Provide informed consent.

Exclusion Criteria:

1. Patients with another malignant disease.
2. Patients with uncontrolled active infection.
3. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
4. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
5. Patients with uncontrolled active bleeding.
6. Patients who has participated or participating in other clinical trials related to this disease.
7. Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
8. Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
9. Patients with other commodities that the investigators considered not suitable for the enrollment.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiaowen Tang, Ph.D

Conditions Ph-Positive Acute Lymphoblastic Leukemia; Ph-positive ALL; Venetoclax+Azacitidine+Orebatinib