Acute Myeloid LeukemiaPhase 2NCT05918198
Clinical Study of Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia
A Phase 2 study testing Ven+CAG in people with Acute Myeloid Leukemia, run by Peking University People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to test the safety and efficacy of venetoclax plus CAG regimen in refractory/relapsed acute myeloid leukemia patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Ven+CAG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤ age ≤ 75 years, male and female are not limited.
- According to bone marrow morphology and immunophenotype, it was diagnosed as acute myeloid leukemia ( WHO 2016 diagnostic criteria).
- Morphological recurrence after complete remission (CR) (leukemic cells in the peripheral blood of CR patients or more than 5% of the blasts in the bone marrow or new pathological hematopoiesis or extramedullary leukemic cell infiltration) or acute myeloid leukemia patients who did not achieved CR after 1 cycle of chemotherapy.
- The ECOG (Eastern Cancer Cooperation Group of the United States) PS score is 0-1.
- The expected survival time is ≥ 12 weeks.
- Female patients of childbearing age need to undergo pregnancy examination before receiving chemotherapy, and must agree to take effective contraceptive measures during treatment.
- Subjects volunteered to participate, fully informed consent, signed an informed consent, and good compliance.
Who cannot join
- Other malignant hematological diseases that do not conform to the diagnosis of acute myeloid leukemia.
- Allergy to any drugs involved in the project.
- History of serious cardiovascular and cerebrovascular diseases: ① Congestive heart failure, unstable angina pectoris, myocardial infarction, stroke or poorly controlled arrhythmia with NYHA grade II or above occurred within 12 months before enrollment，LVEF (left ventricular ejection fraction)<50% by color Doppler ultrasound，Corrected QT interval (QTc)>480ms (calculated by Fridericia method, if the QTc is abnormal, it can be detected continuously for 3 times every 2 minutes, and the average value is taken)，Hypertension difficult to control by drugs (systolic blood pressure (BP) ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg) (based on the average of ≥ 3 BP readings obtained from ≥ 2 measurements)，Have had hypertensive crisis or hypertensive encephalopathy in the past.
- There are other obvious bleeding tendencies or evidence of major coagulation disorders: ①Hemoptysis of any reason occurred within 2 weeks before enrollment，② Thrombosis or embolism occurred within 6 months before enrollment，③ Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin therapy) be used within 2 weeks before enrollment④ Antiplatelet therapy is required.
- Abnormal liver function: total bilirubin>3 mg/dL；Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 5 × Upper limit of normal value (ULN).
- Abnormal renal function: serum creatinine ≥ 1.5 × ULN, or the creatinine clearance rate (CrCl) calculated according to Cockroft-Gault formula is less than 60 mL/min (if the calculated CrCl is less than 60 mL/min, the researcher may ask to confirm the 24-hour CrCl, in this case, the subjects with 24-hour CrCl less than 60 mL/min should be excluded).
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- Other serious diseases that may limit the patient's participation in this clinical trial (including but not limited to other malignant tumors, active infection, serious uncured wounds, active ulcers and untreated fractures, history of human immunodeficiency virus infection, and receiving allogeneic stem cells or solid organ transplantation).
- Cannot swallow pills, malabsorption syndrome or any condition that affects gastrointestinal absorption.
- Other clinical trials are being conducted.
- Unable to understand or cooperate to complete the research protocol.
- Pregnant and lactating patients
- Other situations that the researcher believes are not suitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Wen-Jing Yu, 18813187365, yuwenjing789@126.com
About this study
Official title: Clinical Study of BCL-2 Inhibitor Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia
The goal of this clinical trial is to test the safety and efficacy of venetoclax plus CAG regimen in refractory/relapsed acute myeloid leukemia patients.
Read the detailed description
The main questions it aims to answer are:
- Safety of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients
- Efficacy of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients Participants will receive therapy of venetoclax and CAG regimen (Ara-C, Acla and C C-GSF)
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Ven+CAG
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ven+CAGDrug
Also called Venetoclax plus CAG regimen
100 mg on the first day, and then gradually increase to the target dose of 400 mg (100 mg d1, 200 mg d2, 400 mg d3) within 3 days; After that, the drug continued to be administered until the 14th day, 400 mg/day. When combined with CYP3A or P-gp inhibitors (mainly voriconazole in this study), adjust the venetoclax dose to 100 mg/day.
Ara-C 10mg/m2, ih, q12h × 14d； Acla 20mg/d × 4d； G-CSF 5ug/kg × 14d (WBC > 30 × 10^9/L pause)
| Study group | Role | What they receive |
|---|---|---|
| Ven+CAG | Experimental | Venetoclax plus CAG regimen Receives: Drug: Ven+CAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR/CRi rate
the rate of complete remission or complete remission with incomplete hematologic recovery
Measured: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
CR/CRi rate
the rate of complete remission or complete remission with incomplete hematologic recovery
Measured: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
Secondary outcomes (7)
MRD status
MRD-positive status was defined as FCM positivity in two consecutive BM samples at a 2-week interval, PCR positivity in two consecutive BM samples at a 2-week interval, or both FCM and PCR positivity in a single BM sample after the first-month post-HSCT. Positive FCM was defined as >0.01% of cells with a LAIPs phenotype in >1 BM samples after transplantation. The expressions of leukemia-associated genes were evaluated by TaqMan-based RT-PCR, including Wilms' tumor gene 1 (WT1) and genes which were determined in the diagnostic specimens.
Measured: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
MRD status
MRD-positive status was defined as FCM positivity in two consecutive BM samples at a 2-week interval, PCR positivity in two consecutive BM samples at a 2-week interval, or both FCM and PCR positivity in a single BM sample after the first-month post-HSCT. Positive FCM was defined as >0.01% of cells with a LAIPs phenotype in >1 BM samples after transplantation. The expressions of leukemia-associated genes were evaluated by TaqMan-based RT-PCR, including Wilms' tumor gene 1 (WT1) and genes which were determined in the diagnostic specimens.
Measured: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
objective remission rate（ORR）
The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time.
Measured: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
objective remission rate（ORR）
The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time.
Measured: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
Progression-free survival (PFS)
From date of Ven plus CAG therapy beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Measured: Throughout the whole research process, assessed up to 24 months
Overall survival
From date of Ven plus CAG therapy beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Measured: Throughout the whole research process, assessed up to 24 months
The incidence of adverse events
According to Common Terminology Criteria for Adverse Events, CTCAE, V5.0, assessed up to 24 months
Measured: Throughout the whole research process, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Jing Yu, MD, Peking University People's Hospital
- Investigators
- Wen-Jing Yu, M.D., Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918198
- Sponsor's protocol ID
- RDL2022-13
- Status last verified
- Nov 2023
- First submitted
- 24 May 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of BCL-2 Inhibitor Venetoclax Combined With CAG in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05918198
- Acronym / sponsor ID
- RDL2022-13
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2023 (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.
The goal of this clinical trial is to test the safety and efficacy of venetoclax plus CAG regimen in refractory/relapsed acute myeloid leukemia patients.
Detailed description
The main questions it aims to answer are:
- Safety of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients
- Efficacy of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients Participants will receive therapy of venetoclax and CAG regimen (Ara-C, Acla and C C-GSF)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ven+CAG | Experimental | Drug: Ven+CAGVenetoclax plus CAG regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years ≤ age ≤ 75 years, male and female are not limited.
- According to bone marrow morphology and immunophenotype, it was diagnosed as acute myeloid leukemia ( WHO 2016 diagnostic criteria).
- Morphological recurrence after complete remission (CR) (leukemic cells in the peripheral blood of CR patients or more than 5% of the blasts in the bone marrow or new pathological hematopoiesis or extramedullary leukemic cell infiltration) or acute myeloid leukemia patients who did not achieved CR after 1 cycle of chemotherapy.
- The ECOG (Eastern Cancer Cooperation Group of the United States) PS score is 0-1.
- The expected survival time is ≥ 12 weeks.
Key exclusion criteria (12 listed)
- Other malignant hematological diseases that do not conform to the diagnosis of acute myeloid leukemia.
- Allergy to any drugs involved in the project.
- History of serious cardiovascular and cerebrovascular diseases: ① Congestive heart failure, unstable angina pectoris, myocardial infarction, stroke or poorly controlled arrhythmia with NYHA grade II or above occurred within 12 months before enrollment，LVEF (left ventricular ejection fraction)<50% by color Doppler ultrasound，Corrected QT interval (QTc)>480ms (calculated by Fridericia method, if the QTc is abnormal, it can be detected continuously for 3 times every 2 minutes, and the average value is taken)，Hypertension difficult to control by drugs (systolic blood pressure (BP) ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg) (based on the average of ≥ 3 BP readings obtained from ≥ 2 measurements)，Have had hypertensive crisis or hypertensive encephalopathy in the past.
- There are other obvious bleeding tendencies or evidence of major coagulation disorders: ①Hemoptysis of any reason occurred within 2 weeks before enrollment，② Thrombosis or embolism occurred within 6 months before enrollment，③ Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin therapy) be used within 2 weeks before enrollment④ Antiplatelet therapy is required.
- Abnormal liver function: total bilirubin>3 mg/dL；Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 5 × Upper limit of normal value (ULN).
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 |
|---|---|---|
| Ven+CAGAlso: Venetoclax plus CAG regimen100 mg on the first day, and then gradually increase to the target dose of 400 mg (100 mg d1, 200 mg d2, 400 mg d3) within 3 days; After that, the drug continued to be administered until the 14th day, 400 mg/day. When combined with CYP3A or P-gp inhibitors (mainly voriconazole in this study), adjust the venetoclax dose to 100 mg/day. Ara-C 10mg/m2, ih, q12h × 14d； Acla 20mg/d × 4d； G-CSF 5ug/kg × 14d (WBC > 30 × 10^9/L pause) | Drug | Ven+CAG |
Primary outcome
CR/CRi rate
Time frame: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
the rate of complete remission or complete remission with incomplete hematologic recovery
CR/CRi rate
Time frame: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
the rate of complete remission or complete remission with incomplete hematologic recovery
7 secondary outcomes
MRD status
Time frame: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
MRD status
Time frame: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
objective remission rate（ORR）
Time frame: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
objective remission rate（ORR）
Time frame: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
Progression-free survival (PFS)
Time frame: Throughout the whole research process, assessed up to 24 months
Overall survival
Time frame: Throughout the whole research process, assessed up to 24 months
The incidence of adverse events
Time frame: Throughout the whole research process, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No. Undecided
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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. This study is not recruiting at the moment.
Wen-Jing Yu, M.D. study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ven+CAG in people with Acute Myeloid Leukemia, run by Peking University People's Hospital 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Jing Yu, M.D. (18813187365, yuwenjing789@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR/CRi rate (time frame: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)). The study lists 2 primary outcomes in all. 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 21 Nov 2023.