Acute Myeloid LeukemiaPhase 2LD-VenExNCT05431257
Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling
A Phase 2 study testing Venetoclax in people with Acute Myeloid Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteDenmark
- Study dates
- 24 May 2022to 1 Sep 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients who present with one of the following (except acute promyelocytic leukemia).
- De novo or secondary AML unfit for standard induction therapy
- Relapsed/refractory AML after at least 1 line of prior therapies
- Written informed consent to participate in an exploratory research protocol including bio-banking, comprehensive AML profiling (genomics, transcriptomics, proteomics, etc.) and ex vivo drug sensitivity testing to assess venetoclax and other drug sensitivities.
- All patients are treated with azacitidine+venetoclax irrespective of the ex vivo screening results.
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- ECOG Performance status ≤ 2 for patients ≥ 75 years of age OR ≤ 3 for patients ≥ 18 to 74 years of age.
- Leukocyte count < 25 x10E9/l. Hydroxyurea use is permitted to meet this criterion
- Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined by the Cockcroft Gault formula.
- Adequate liver function as demonstrated by
- alanine aminotransferase (ALT) ≤ 4.0 × ULN.
- bilirubin ≤ 1.5 × ULN.
- Specific inclusion criteria for elderly/unfit AML patients:
- ≥ 70 years of age OR
- ≥ 18 to 69 years of age and ineligible for intensive chemotherapy meeting at least one of the following criteria:
- Clinically significant comorbidities, as reflected by at least 1 of the following criteria:
- Left ventricular ejection fraction (LVEF) < 50%.
- Lung diffusion capacity for carbon monoxide (DLCO) ≤ 65% of expected.
- Forced expiratory volume in 1 second (FEV1) ≤ 65% of expected.
- Chronic stable angina or congestive heart failure controlled with medication.
- Alanine aminotransferase (ALT) 3.0-4.0 × ULN.
- Other contraindication(s) to anthracycline therapy (must be documented).
- Adverse risk genetics (ELN criteria) associated with poor outcome with standard chemotherapy.
- Patient declines intensive chemotherapy.
- Secondary AML after previous disease modifying treatment (i.e. HMA/induction chemotherapy and/or allogeneic stem cell transplantation) of clonal myeloid diseases such as MDS, MDS/MPN, or MPN.
- Specific inclusion criteria for relapsed AML patients:
- ≥ 55 years of age with non-CBF AML relapse OR
- ≥ 18 of age and meeting at least one of the following criteria:
- Not candidate for intensive chemotherapy (see criterion 8).
- Relapse after chemotherapy, or monotherapy with HMA, or allogeneic stem cell transplantation. (note: patients with 4th or higher relapse are excluded).
- Patient declines intensive chemotherapy.
- Specific inclusion criteria for refractory AML patients:
- Patients who fail to achieve a complete or partial remission after previous monotherapy with HMA or induction chemotherapy (at least 1 cycle of chemotherapy containing cytarabine or clofarabine, in combination with a topoisomerase II inhibitor (e.g. anthracycline or mitoxantrone).
Who cannot join
- Acute promyelocytic leukemia (APL).
- Patients with 4th or higher AML relapse.
- Leukemic cell content (blast percentage) in bone marrow/peripheral blood < 10 %.
- ECOG >3.
- Prior venetoclax treatment for myeloid malignancy.
- AML patients with CNS involvement (note: cerebrospinal fluid or radiological investigations are not required without clinical suspicion).
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- HIV infection or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection that is not controlled with antiviral medication with the definition hereof at the discretion of the investigator.
- Cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in palpitations, fatigue, dyspnea, or anginal pain.
- Evidence of clinically significant condition(s), which at the investigator's discretion would adversely affect the patient's participation in this study (including but not limited to):
- Chronic respiratory disease that requires continuous oxygen use.
- Systemic uncontrolled infection requiring therapy (viral, bacterial or fungal).
- Malabsorption syndrome or other condition that precludes enteral route of administration.
- Uncontrolled GVHD.
- Previous malignancies with the exception of previous malignancy treated successfully with curative intent and indolent/smoldering malignancies (defined at the investigator's discretion).
- Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment).
- Fertile men or women of childbearing potential unless:
- Surgically sterile or ≥ 2 years after the onset of menopause.
- Willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 3 months after the end of study treatment.
- Known hypersensitivity to venetoclax or azacitidine or excipients of any of the drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Hematology, Rigshospitalet
Copenhagen, 2100
Mette H Thrane, Master of Public Health, +4535450944, mette.hoejmose.thrane.01@regionh.dk
Julie Palmer Rohold, MSc, +4535455111, julie.palmer.rohold@regionh.dk
About this study
Official title: Phase II Study of Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With Acute Myeloid Leukemia With Integration of Explorative Multi-omics and ex Vivo Drug Screening Data
Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia.
AZA and LD-VEN treatment is combined with exploratory AML profiling using established platforms for OMICs analyses and ex vivo drug sensitivity and resistance testing. This will validate the feasibility of AML profiling in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program will also identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients in future clinical trial initiatives.
Read the detailed description
Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia.
AML patients will be subjected to conventional diagnostic workup to assess if they fulfil eligibility criteria. As part of the exploratory trial program, bone marrow (BM) and peripheral blood (PB) samples will be subjected to functional AML profiling including OMICs analyses and immediate ex vivo drug sensitivity and resistance testing (DSRT). The treatment period with AZA/LD-VEN begins after completion of the diagnostic workup period, and includes drug treatment, clinical assessment, QoL assessment, and analysis of relevant follow-up BM and PB samples according to a detailed study event schedule. Patients will receive repeated cycles of treatment with AZA (D1-D7, 75mg/m2 qd) in combination with LD-VEN (D1-D14 before CR and D1-D7 after CR, 400mg qd) every 4 weeks. Patients exhibiting clinical response will continue treatment with AZA/LD-VEN for a maximum of two years or until withdrawal of consent, disease progression, unacceptable toxicity, intolerance, lack of compliance, unresponsiveness after three cycles of study treatment, or if they obtain CR and proceed to allogeneic stem cell transplantation. Clinical response (CR/CRi/MLFS=morphologic leukemia-free state/PR=partial remission), survival information (OS/DOR=duration of response/EFS=event-free survival), and QoL data will be collected for all patients independently on their response to AZA/LD-VEN treatment. Survival information and post-treatment follow-up (i.e. all post-treatment AML therapies including dates of initiation and completion, the date and cause of death) will be collected every three months for the first two years and thereafter annually for the following three years after End-Of-Treatment or withdrawal from study treatment, or until death of the patient.
The exploratory program will validate the feasibility of comprehensive OMICs profiling and ex vivo drug sensitivity and resistance testing in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program is expected to identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients that are refractory or suffer from relapse after AZA/LD-VEN treatment in future clinical trial initiatives.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax
- 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.
VenetoclaxDrug
Standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia.
| Study group | Role | What they receive |
|---|---|---|
| Elderly/unfit AML patients or sec. and R/R AML patients | Experimental | Not described Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
ORR(%) = CR rate(%)+CRi rate(%)+MLFS(%)
Measured: 1-1,5 year
Composite complete remission rate
Composite CR rate (%) = CR rate (%) + CRh rate (%)
Measured: 1-1,5 year
Partial remission rate
PR rate (%)
Measured: 1-1,5 year
Secondary outcomes (8)
Overall survival
Overall survival (OS) (months)
Measured: 3,5-5 years
Duration of response
Duration of response (DOR) (months)
Measured: 3,5-5 years
Event free survival
Event free survival (EFS) (months)
Measured: 3,5-5 years
Frequency and severity of adverse events
Frequency and severity of adverse events (hematologic toxicities-AE grade 3+4, febrile neutropenia, days until neutrophil recovery ≥ 0.5 x 10E9/l and platelet recovery ≥ 50 x 10E9/l, severe AE grade 3+4).
Measured: 3-3,5 years
The correlation of ex vivo drug sensitivity with specific clinical responses
The correlation of ex vivo drug sensitivity with specific clinical responses (OS, DOR, EFS, MRD status).
Measured: 1,5-2 years
The correlation of venetoclax blood concentrations with specific responses
The correlation of venetoclax blood concentrations with specific responses (OS, DOR, EFS, MRD status).
Measured: 1,5-2 years
Quality-of-Life
Quality-of-Life (QoL) as assessed by European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire - C30 (EORTC-QLQ-C30), including domains and scale 1-4 - (1) Not at all, (2) a little, (3) quite a bit, (4) very much.
Measured: 3-3,5 years
Quality-of-Life
Quality-of-Life (QoL) as assessed by European Quality-of-Life - 5 Dimensions - 5 Level (EQ-5D-5L) questionnaire, including EQ-5D domains and visual analogue scale (VAS score 0-100).
Measured: 3-3,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start24 May 2022
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (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 Copenhagen University Hospital, RigshospitaletThe 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
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, University Hospital of North Norway, Haukeland University Hospital, St. Olavs Hospital, Vestre Viken Hospital Trust, Helse Møre og Romsdal HF, Karolinska University Hospital, Skane University Hospital, Uppsala University Hospital, Helsinki University Central Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
- Responsible party
- Principal investigator, Kim Theilgaard-Mönch, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431257
- Sponsor's protocol ID
- H-21030117
- Acronym
- LD-VenEx
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With Acute Myeloid Leukemia With Integration of Explorative Multi-omics and ex Vivo Drug Screening Data
- ClinicalTrials.gov ID
- NCT05431257
- Acronym / sponsor ID
- LD-VenEx / H-21030117
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, University Hospital of North Norway, Haukeland University Hospital, St. Olavs Hospital, Vestre Viken Hospital Trust, Helse Møre og Romsdal HF, Karolinska University Hospital, Skane University Hospital, Uppsala University Hospital, Helsinki University Central Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
- Study start
- 24 May 2022 (actual)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 24 Jun 2022 (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.
Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia.
AZA and LD-VEN treatment is combined with exploratory AML profiling using established platforms for OMICs analyses and ex vivo drug sensitivity and resistance testing. This will validate the feasibility of AML profiling in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program will also identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients in future clinical trial initiatives.
Detailed description
Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia.
AML patients will be subjected to conventional diagnostic workup to assess if they fulfil eligibility criteria. As part of the exploratory trial program, bone marrow (BM) and peripheral blood (PB) samples will be subjected to functional AML profiling including OMICs analyses and immediate ex vivo drug sensitivity and resistance testing (DSRT). The treatment period with AZA/LD-VEN begins after completion of the diagnostic workup period, and includes drug treatment, clinical assessment, QoL assessment, and analysis of relevant follow-up BM and PB samples according to a detailed study event schedule. Patients will receive repeated cycles of treatment with AZA (D1-D7, 75mg/m2 qd) in combination with LD-VEN (D1-D14 before CR and D1-D7 after CR, 400mg qd) every 4 weeks. Patients exhibiting clinical response will continue treatment with AZA/LD-VEN for a maximum of two years or until withdrawal of consent, disease progression, unacceptable toxicity, intolerance, lack of compliance, unresponsiveness after three cycles of study treatment, or if they obtain CR and proceed to allogeneic stem cell transplantation. Clinical response (CR/CRi/MLFS=morphologic leukemia-free state/PR=partial remission), survival information (OS/DOR=duration of response/EFS=event-free survival), and QoL data will be collected for all patients independently on their response to AZA/LD-VEN treatment. Survival information and post-treatment follow-up (i.e. all post-treatment AML therapies including dates of initiation and completion, the date and cause of death) will be collected every three months for the first two years and thereafter annually for the following three years after End-Of-Treatment or withdrawal from study treatment, or until death of the patient.
The exploratory program will validate the feasibility of comprehensive OMICs profiling and ex vivo drug sensitivity and resistance testing in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program is expected to identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients that are refractory or suffer from relapse after AZA/LD-VEN treatment in future clinical trial initiatives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly/unfit AML patients or sec. and R/R AML patients | Experimental | Drug: Venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Written informed consent.
- Patients who present with one of the following (except acute promyelocytic leukemia).
- Written informed consent to participate in an exploratory research protocol including bio-banking, comprehensive AML profiling (genomics, transcriptomics, proteomics, etc.) and ex vivo drug sensitivity testing to assess venetoclax and other drug sensitivities.
- ECOG Performance status ≤ 2 for patients ≥ 75 years of age OR ≤ 3 for patients ≥ 18 to 74 years of age.
- Leukocyte count < 25 x10E9/l. Hydroxyurea use is permitted to meet this criterion
Key exclusion criteria (19 listed)
- Acute promyelocytic leukemia (APL).
- Patients with 4th or higher AML relapse.
- Leukemic cell content (blast percentage) in bone marrow/peripheral blood < 10 %.
- ECOG >3.
- Prior venetoclax treatment for myeloid malignancy.
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 |
|---|---|---|
| VenetoclaxStandard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia. | Drug | Elderly/unfit AML patients or sec. and R/R AML patients |
Primary outcome
Overall response rate
Time frame: 1-1,5 year
ORR(%) = CR rate(%)+CRi rate(%)+MLFS(%)
Composite complete remission rate
Time frame: 1-1,5 year
Composite CR rate (%) = CR rate (%) + CRh rate (%)
Partial remission rate
Time frame: 1-1,5 year
PR rate (%)
8 secondary outcomes
Overall survival
Time frame: 3,5-5 years
Duration of response
Time frame: 3,5-5 years
Event free survival
Time frame: 3,5-5 years
Frequency and severity of adverse events
Time frame: 3-3,5 years
The correlation of ex vivo drug sensitivity with specific clinical responses
Time frame: 1,5-2 years
The correlation of venetoclax blood concentrations with specific responses
Time frame: 1,5-2 years
Quality-of-Life
Time frame: 3-3,5 years
Quality-of-Life
Time frame: 3-3,5 years
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 24 Jun 2022.
- 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 Venetoclax in people with Acute Myeloid Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 33 inclusion and 19 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 24 Jun 2022. 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 Denmark. 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?
Contact Kim Theilgaard-Mönch, MD, DMSc (+4535455197, kim.theilgaard-moench@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 1-1,5 year). 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 24 Jun 2022; AzTrials last refreshed its copy on 26 Oct 2026.