Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07187505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia
Sponsor:
Anhui Medical University
Organization:
Study Overview
Official Title:
Venetoclax Plus All-Trans Retinoic Acid and Arsenic Trioxide in Newly Diagnosed Acute Promyelocytic Leukemia With Hyperleukocytosis: A Prospective Single-Arm Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the safety and effectiveness of combining venetoclax with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) in patients with newly diagnosed acute promyelocytic leukemia (APL) who have very high white blood cell counts. APL is a rare type of blood cancer, and patients with high white blood cell levels often face serious complications. Current treatments with ATRA and ATO are effective, but the outcomes for patients with high white blood cells remain poor. This study will test whether adding venetoclax, a drug that helps leukemia cells die, can improve treatment results.
Detailed Description:
PRIMARY OBJECTIVE 1. To evaluate the efficacy of the venetoclax + ATRA + ATO regimen, as defined by complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and morphological leukemia-free state (MLFS).
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ SECONDARY OBJECTIVES
1. To evaluate long-term effectiveness and durability of the regimen, as defined by 1-year overall survival (OS), 1-year event-free survival (EFS), and overall response rate (ORR).
2. To evaluate the safety of the regimen, as defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, differentiation syndrome, and treatment-related mortality (TRM).
3. To assess transfusion requirements (red blood cells and platelets) during induction.
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ OUTLINE
* Newly diagnosed hyperleukocytosis group: Patients with baseline WBC \>10 × 10⁹/L will receive venetoclax + ATRA + ATO as induction therapy.
* Secondary hyperleukocytosis group: Patients who develop WBC \>10 × 10⁹/L for ≥3 consecutive days during therapy will receive venetoclax added dynamically to ATRA + ATO.
Induction regimen:
* Venetoclax (VEN): 100 mg orally once daily on days 1-7. For patients with WBC \>100 × 10⁹/L, administer 50 mg on days 1-2, then escalate to 100 mg on days 3-7.
* All-Trans Retinoic Acid (ATRA): 25 mg/m² orally per day (divided doses), on days 1-28.
* Arsenic Trioxide (ATO): 0.15 mg/kg intravenously once daily, on days 1-28.
Assessment:
* Complete blood counts monitored regularly.
* Bone marrow evaluation on days 14 and 28.
* One treatment cycle lasts 28 days.
Response evaluation:
* On day 21 of the first cycle, bone marrow assessment will be performed.
* If CR, CRi, or MLFS is not achieved, induction with the same regimen will continue for one additional cycle.
* Patients failing to achieve remission after two cycles will be withdrawn from the study.
* Patients achieving remission will proceed to consolidation and maintenance therapy according to investigator's discretion.
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ SECONDARY OBJECTIVES
1. To evaluate long-term effectiveness and durability of the regimen, as defined by 1-year overall survival (OS), 1-year event-free survival (EFS), and overall response rate (ORR).
2. To evaluate the safety of the regimen, as defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, differentiation syndrome, and treatment-related mortality (TRM).
3. To assess transfusion requirements (red blood cells and platelets) during induction.
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ OUTLINE
* Newly diagnosed hyperleukocytosis group: Patients with baseline WBC \>10 × 10⁹/L will receive venetoclax + ATRA + ATO as induction therapy.
* Secondary hyperleukocytosis group: Patients who develop WBC \>10 × 10⁹/L for ≥3 consecutive days during therapy will receive venetoclax added dynamically to ATRA + ATO.
Induction regimen:
* Venetoclax (VEN): 100 mg orally once daily on days 1-7. For patients with WBC \>100 × 10⁹/L, administer 50 mg on days 1-2, then escalate to 100 mg on days 3-7.
* All-Trans Retinoic Acid (ATRA): 25 mg/m² orally per day (divided doses), on days 1-28.
* Arsenic Trioxide (ATO): 0.15 mg/kg intravenously once daily, on days 1-28.
Assessment:
* Complete blood counts monitored regularly.
* Bone marrow evaluation on days 14 and 28.
* One treatment cycle lasts 28 days.
Response evaluation:
* On day 21 of the first cycle, bone marrow assessment will be performed.
* If CR, CRi, or MLFS is not achieved, induction with the same regimen will continue for one additional cycle.
* Patients failing to achieve remission after two cycles will be withdrawn from the study.
* Patients achieving remission will proceed to consolidation and maintenance therapy according to investigator's discretion.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: