Treatment for newly diagnosed Philadelphia Chromosome-positive 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 phase 2, single-arm, open-label study evaluates the efficacy and safety of a combination treatment involving Olverembatinib, a CD3/CD19 bispecific T-cell engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). The study aims to achieve complete molecular remission (CMR) within three months and assess overall survival and event-free survival as secondary endpoints. The approach combines targeted therapies and immunotherapy to improve outcomes for patients who are ineligible for allogeneic hematopoietic stem cell transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent;
2. Newly diagnosed adult B-precursor Ph+ ALL;
3. Age greater or equal to 18 years;
4. ECOG Performance Status 0-1;
5. Ineligible for allo-HSCT.
6. Renal and hepatic function as defined below:

   AST (GOT), ALT (GPT), and AP \<2 x upper limit of normal (ULN). Creatinine clearance equal or greater than 50 mL/min.
7. Pancreatic function as defined below:

   Serum amylase less or equal to 1.5 x ULN Serum lipase less or equal to1.5 x ULN
8. Normal cardiac function;
9. Negative HIV test, negative HBV DNA and HCV RNA;
10. Negative pregnancy test in women of childbearing potential.

Exclusion Criteria:

History of receiving systemic chemotherapy or CAR-T therapy for ALL.

Impaired cardiac function, including any one of the following:

.LVEF \<45% as determined by MUGA scan or echocardiogram. .Complete left bundle branch block. .Use of a cardiac pacemaker.

* ST depression of \>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads. .Congenital long QT syndrome. .History of or presence of significant ventricular or atrial arrhythmia. .Clinically significant resting bradycardia (\<50 beats per minute). .QTc \>450 msec on screening ECG (using the QTcF formula). .Right bundle branch block plus left anterior hemiblock, bifascicular block. .Myocardial infarction within 3 months prior to starting olverembatinib . .Angina pectoris.
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of olverembatinib or chidamide (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). .History of or current autoimmune disease. .History of or current relevant CNS pathology. .Presence of CNS leukemia. .History of or current autoimmune disease. .History of other malignancies. .Presence active infection.
* Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
* Not eigiable for this study, decided by PI

Where it's running

• Dept of Hematology, Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Hongsheng Zhou, M.D., Ph.D — Department of Hematology Nanfang Hospital
• Study coordinator: Hongsheng Zhou, M.D; Ph.D
• Email: hanson_tcm@hotmail.com
• Phone: +862062787349

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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.