A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jan 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults who have just been diagnosed with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a type of blood cancer. The trial combines three medications: Olverembatinib, Chidamide, and a special treatment called a bispecific T-cell engager. The goal is to see how well this combination works in helping patients achieve complete molecular remission, which means there are no detectable cancer cells in the blood, within three months of starting treatment. Researchers will also look at how long patients survive and how well they live without their cancer progressing.

To participate in this trial, patients need to be at least 18 years old and newly diagnosed with Ph+ ALL. They should not have previously received chemotherapy for this condition and must meet certain health criteria, such as having normal kidney and liver function. Participants will receive the experimental treatment and will be monitored for any side effects and overall health outcomes. It's important for potential participants to discuss the study with their doctors to understand if they meet the eligibility criteria and what being part of the trial entails.

Gender

ALL

Eligibility criteria

• 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