Acute Promyelocytic LeukemiaPhase 2/3Ven APLNCT06544109
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
A Phase 2/3 study testing venetoclax in people with Acute Promyelocytic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Promyelocytic Leukemia
- What is being tested?
- venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient is ineligible for treatment with intensive chemotherapy
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Venetoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
- Conditions
- Acute Promyelocytic Leukemia
- Being tested
- venetoclax
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venetoclaxDrug
patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax
| Study group | Role | What they receive |
|---|---|---|
| Arm Description:the Venatoclax regimen to prevent DS | Experimental | The patient with suspected APL should be treated with ATRA or Venetoclx depending on its WBC counts and rapid diagnosis of APL was made at the same time. Once APL was diagnosed, patients were initially treated with ATRA 25 mg/m2/d and ATO 0.16 mg/kg/d. During the induction regimen, patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax and DS was suspected received dexamethasone or ruxolitinib. Receives: Drug: venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of differential symdrom
DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure.
Measured: the induction regimen (21 days to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544109
- Sponsor's protocol ID
- SZQ002
- Acronym
- Ven APL
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
- ClinicalTrials.gov ID
- NCT06544109
- Acronym / sponsor ID
- Ven APL / SZQ002
- Conditions
- Acute Promyelocytic Leukemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Description:the Venatoclax regimen to prevent DS | Experimental | Drug: venetoclaxThe patient with suspected APL should be treated with ATRA or Venetoclx depending on its WBC counts and rapid diagnosis of APL was made at the same time. Once APL was diagnosed, patients were initially treated with ATRA 25 mg/m2/d and ATO 0.16 mg/kg/d. During the induction regimen, patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax and DS was suspected received dexamethasone or ruxolitinib. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient is ineligible for treatment with intensive chemotherapy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venetoclaxpatients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax | Drug | Arm Description:the Venatoclax regimen to prevent DS |
Primary outcome
the rate of differential symdrom
Time frame: the induction regimen (21 days to 28 days)
DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Related trials for Acute Promyelocytic Leukemia
RecruitingPhase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
RecruitingPhase 1
PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia, Acute Promyelocytic Leukemia With PML-RARA
Not yet recruiting
Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice
Acute Myeloid Leukemia, Acute Myeloid Leukemia, Adult
Active, not recruiting
Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia With PML-RARA, t(15;17)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing venetoclax in people with Acute Promyelocytic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of differential symdrom (time frame: the induction regimen (21 days to 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.