Relapsed Acute Myeloid LeukemiaPhase 2NCT06536959
VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
A Phase 2 study testing PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine in people with Relapsed Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Beijing 302 Hospital at 1 site in China.
Trial summary
The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2024to 31 Jul 2027
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.
- Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.
- Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
- The toxic and side effects caused by the last treatment should be recovered.
- Eastern Cooperative Oncology Group score of 0 to 3 points.
- The organ function is intact.
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- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).
- Creatinine≤2×ULN.
- Bilirubin≤2×ULN.
- Karnofsky≥70.
- The expected survival period is at least 12 weeks.
- Non-pregnant, non-breastfeeding women.
Who cannot join
- Suffering from other untreated or unrelieved malignant tumors within 2 years.
- Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
- Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association [NYHA] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
- Patients who are unwilling or unable to comply with the protocol.
- Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiao-ning Gao
Beijing, Beijing Municipality, 100071
Xiao-ning Gao, 86-010-66947169, gaoxn@263.net
Lei Xu, 86-010-66947174, xulei800@hotmail.com
About this study
Official title: A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS
The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Minimal Residual Disease
- Being tested
- PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
- Keywords
- Venetoclax, Hypomethylation agen, PD-1 inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitor, Venetoclax, Decitabine, AzacytidineDrug
Also called PD-1 inhibitor (Tislelizumab), Venetoclax (ABT-199, GDC-0199), Decitabine (Dacogen, 5-aza-2-deoxycytidine), Azacitidine (5-Azacytidine, Ladakamycin)
For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician.
For MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician.
The venetoclax starting dose is 100 mg on the first day, ramping up to 200 mg on the second day and finally 400 mg once daily. The steady daily dose (after ramp-up phase) should be reduced to 100 mg (coadministered with moderate CYP3A inhibitors or P-gp inhibitors) and 70 mg (coadministered with strong CYP3A4 inhibitors).
| Study group | Role | What they receive |
|---|---|---|
| VA-PD1i | Experimental | Patients are treated with PD-1 inhibitor combined with venetoclax and decitabine/azacytidine. Receives: Drug: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
Measured: At the end of Cycle 2 (each cycle is 28 days)
Complete minimal residual disease (MRD) Response Rate
Percentage of subjects with MRD negative or MRD < 0.01%
Measured: At the end of Cycle 2 (each cycle is 28 days)
MRD Response Rate
Percentage of subjects with MRD < 0.1% detectable by multicolor flow cytometry
Measured: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (4)
Relapse-Free Survival
Time interval from leukemia free state to the first recurrence or death
Measured: 24 months
Overall Survival
Time interval from start of treatment until death or last follow-up
Measured: 24 months
Duration of response
Time interval from morphologic/MRD response to loss of response or death
Measured: 24 months
Adverse events
Number of subjects with adverse events
Measured: start of treatment to 2 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start18 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Ning Gao, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536959
- Sponsor's protocol ID
- VA-PD1-MN
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS
- ClinicalTrials.gov ID
- NCT06536959
- Acronym / sponsor ID
- VA-PD1-MN
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Minimal Residual Disease
- Keywords
- Venetoclax, Hypomethylation agen, PD-1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 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.
The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VA-PD1i | Experimental | Drug: PD-1 inhibitor, Venetoclax, Decitabine, AzacytidinePatients are treated with PD-1 inhibitor combined with venetoclax and decitabine/azacytidine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.
- Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.
- Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
- The toxic and side effects caused by the last treatment should be recovered.
- Eastern Cooperative Oncology Group score of 0 to 3 points.
Key exclusion criteria (6 listed)
- Suffering from other untreated or unrelieved malignant tumors within 2 years.
- Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
- Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association [NYHA] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
- Patients who are unwilling or unable to comply with the protocol.
- Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
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 |
|---|---|---|
| PD-1 inhibitor, Venetoclax, Decitabine, AzacytidineAlso: PD-1 inhibitor (Tislelizumab), Venetoclax (ABT-199, GDC-0199), Decitabine (Dacogen, 5-aza-2-deoxycytidine), Azacitidine (5-Azacytidine, Ladakamycin)For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. For MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. The venetoclax starting dose is 100 mg on the first day, ramping up to 200 mg on the second day and finally 400 mg once daily. The steady daily dose (after ramp-up phase) should be reduced to 100 mg (coadministered with moderate CYP3A inhibitors or P-gp inhibitors) and 70 mg (coadministered with strong CYP3A4 inhibitors). | Drug | VA-PD1i |
Primary outcome
Complete remission rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
Complete minimal residual disease (MRD) Response Rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with MRD negative or MRD < 0.01%
MRD Response Rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with MRD < 0.1% detectable by multicolor flow cytometry
4 secondary outcomes
Relapse-Free Survival
Time frame: 24 months
Overall Survival
Time frame: 24 months
Duration of response
Time frame: 24 months
Adverse events
Time frame: start of treatment to 2 weeks after end of treatment
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 5 Aug 2024.
- Individual participant dataSharing planned: No
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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.
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 PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine in people with Relapsed Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Beijing 302 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 12 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 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 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: At the end of Cycle 2 (each cycle is 28 days)). The study lists 3 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 5 Aug 2024.