Acute Promyelocytic Leukemia,ALL
Conditions
Interventions
Experimental Group:All-trans retinoic acid and arsenic agents combined with venetoclax treatment
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >14 years old; 2. Newly diagnosed APL (morphologically suspected APL and subsequently confirmed PML..RARa positive by quantitative PCR or FISH); 3. ECOG performance status score of 0-2 at screening; 4. White blood count> 10×10E9/L; 5. Negative pregnancy test result for women of childbearing potential 6. Prior use of retinoic acid for less than 7 days is permitted, with a requirement of white blood cell count> 10×10E9/L; 7. Understand the study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. PML..RARa negativity confirmed by quantitative PCR or FISH; 2. Patients with difficulty in oral medication intake or malabsorption syndrome; 3. Concomitant diseases with abnormal cardiac, pulmonary, hepatic, renal or other vital organ functions that may restrict participation in this trial (including but not limited to severe infection, uncontrolled diabetes, severe cardiac insufficiency or angina pectoris, active pulmonary tuberculosis, asthma, COPD, bronchiectasis; creatinine clearance 5.0×ULN, alanine aminotransferase (ALT) > 5.0×ULN, total bilirubin > 1.5×ULN, unless deemed secondary to leukemic organ infiltration or Gilbert’s syndrome); 4. QTc interval > 0.47 s; 5. History of other malignancies within 5 years prior to study entry, excluding. fully treated cervical carcinoma in situ or breast carcinoma in situ; basal cell carcinoma of the skin or localized cutaneous squamous cell carcinoma; previous malignancies with sustained disease control after radical surgical resection (or other curative treatments); 6. Central nervous system leukemia infiltration or hemorrhage; 7. Known HIV infection; 8. Prior exposure to chemotherapy such as anthracyclines and cytarabine (excluding leukoreductive treatment with a total dose not exceeding the standard single-day dose); 9. Inability to understand or comply with the study protocol; 10. Subjects receiving strong or moderate CYP3A inducers/inhibitors within 7 days before the initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival at 3month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differentiation Syndrome;Cumulative recurrence rate;Complete remission rate;Molecular remission rate;2-year event-free survival, EFS;2year OS;early death;relapse free survival;Adverse events; | — |
Countries
China
Contacts
Public ContactYinjun Lou, Jie Jin
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed