NCT06544109Enrolling by invitationPhase 2/3
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Venetoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 6 Aug 2024
- Start date
- 1 Aug 2023
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT06544109
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 98
- From 1 Aug 2023 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is ineligible for treatment with intensive chemotherapy
Other illness
- Patient with active infection not controlled, active bleeding from vital organs
- Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
Who the study is looking for
- Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
- patients must have confirmation of APL by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \< 45 mL/min. Moderate hepatic impairment with total bilirubin \> 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qiu huiying Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.