AML, AdultPhase 2HO171NCT06014489
A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML
A Phase 2 study testing azacitidine, Venetoclax and Cobicistat in people with AML, Adult, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 19 sites in Netherlands.
Trial summary
The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- azacitidine, Venetoclax and Cobicistat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 19 sitesNetherlands
- Study dates
- 17 Jan 2024to Dec 2028
- 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
- In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia) (appendix A). Patients may have had previous treatment with erythropoiesis stimulating agents (ESA) for an antecedent phase of MDS. ESAs must be stopped at least two weeks before registration.
- Patients 18 years and older who are considered not fit for intensive chemotherapy or who decline the option of intensive chemotherapy.
- WHO performance status 0, 1 or 2 (appendix E).
- Leukocytes < 30 x109/L
- Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
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- Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
- Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert's syndrome.
- Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related.
- Male subjects who are sexually active, must agree, from Study Day 1 until at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.
- Female subjects must be either postmenopausal defined as: Age >55 years with no menses for ≥12 months, without an alternative medical cause. OR willing and able to use adequate contraception during and until 180 days after the last protocol treatment.
- Written informed consent.
- Patient is capable of giving informed consent.
- Patient agrees not to participate in another interventional study while on treatment without approval of the (co-) Principal Investigator.
Who cannot join
- A patient who meets any of the following criteria cannot be included in this study:
- Acute promyelocytic leukemia.
- Myelodysplastic syndrome (MDS).
- Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating agents (ESAs); 2) hydroxyurea ((previous treatment with hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis).
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion:
- except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 24 months prior to registration;
Show all 22Show fewer
- except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Blast crisis of chronic myeloid leukemia.
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.).
- Cardiac dysfunction as defined by:
- Myocardial infarction within the last 3 months of study entry, or
- Reduced left ventricular function with an ejection fraction < 40% as measured by MUGA scan or echocardiogram, or
- Unstable angina or New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix G), or
- Unstable cardiac arrhythmias.
- History of stroke or intracranial haemorrhage within 6 months prior to registration.
- Symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement).
- History of non-compliance to medical regimens or considered unreliable with respect to compliance.
- Senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
- Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Unreplaceable use of strong inhibitors or inducers of CYP3A or CYP3A/p-GP substrates with a narrow therapeutic window (e.g. cobicistat or ritonavir for HIV treatment). Please check with Appendix I.
- Intolerability, contra-indication or allergy to one of the study drugs.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Netherlands19 sites, 19 recruiting
- Recruiting
NL-Den Bosch-JBZ
's-Hertogenbosch
A.H.E. Herbers, Dr.
- Recruiting
NL-Amersfoort-MEANDERMC
Amersfoort
M.F. Corsten, Dr.
- Recruiting
NL-Amsterdam-AUMC
Amsterdam
C. Alhan, Dr.
- Recruiting
NL-Amsterdam-OLVG
Amsterdam
H. Mooij, Dr.
- Recruiting
NL-Arnhem-RIJNSTATE
Arnhem
M.L.H. Cuijpers, Dr.
- Recruiting
NL-Breda-AMPHIA
Breda
R.B. Fiets, Dr.
- Recruiting
NL-Dordrecht-ASZ
Dordrecht
P.E. Westerweel, Dr.
- Recruiting
NL-Eindhoven-CATHARINA
Eindhoven
M.J. Cruijsen, Dr.
- Recruiting
NL-Eindhoven-MAXIMAMC
Eindhoven
L.W. Tick, Dr.
- Recruiting
NL-Enschede-MST
Enschede
T.J.F. Snijders, Dr.
- Recruiting
NL-Groningen-UMCG
Groningen
G.A. Huls, Prof. dr.
- Recruiting
NL-Leeuwarden-MCL
Leeuwarden
B. Franken, Dr.
- Recruiting
NL-Leiden-LUMC
Leiden
P.A. von dem Borne, Dr.
- Recruiting
NL-Maastricht-MUMC
Maastricht
C.H.M.J. van Elssen, Dr.
- Recruiting
NL-Nieuwegein-ANTONIUS
Nieuwegein
O. de Weerdt, Dr.
- Recruiting
NL-Nijmegen-CWZ
Nijmegen
S. de Jonge, Dr.
- Recruiting
NL-Nijmegen-RADBOUDUMC
Nijmegen
N.A. de Jonge, Dr.
- Recruiting
NL-Den Haag-HAGA
The Hague
D. van Lammeren, Dr.
- Recruiting
NL-Zwolle-ISALA
Zwolle
T.T. de Waal, Dr.
About this study
Official title: A Single Arm Phase II Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine (sc) in Adult Patients With Newly Diagnosed Acute Myeloid Leukaemia (AML) Who Are Not Considered Candidates for Intensive Treatment Regimens
The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.
- Conditions
- AML, Adult
- Being tested
- azacitidine, Venetoclax, Cobicistat
- 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.
azacitidineDrug
during run-in and extention phase: from Cycle 1 until relapse
VenetoclaxDrug
during run-in and extention phase: from Cycle 1 until relapse
CobicistatDrug
during run-in phase: from cycle 2 until relapse
during extension phase: from cycle 1 until relapse
| Study group | Role | What they receive |
|---|---|---|
| single arm arm extension phase | Experimental | prior to the extention phase, there is a run-in phase with (n= 20 patients of 142 total) with the same study scheme, except that cobicistat is added from cycle 2 onwards to the treatment instead of during cycle 1 Receives: Drug: azacitidine; Drug: Venetoclax; Drug: Cobicistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2).venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2).
run-in phase
Measured: 6-8 months
Overall survival (OS).
extension phase
Measured: 48 months
Secondary outcomes (20)
Venetoclax and cobicistat CL, Cmax, Tmax, Cmin and AUC0-24.
run-in phase
Measured: 6-8 months
Complete remission (CR) rate defined as CR as best response during or at completion of the treatment, as determined by the Investigator, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B).
extension phase
Measured: 48 months
CR with incomplete hematologic recovery (CRi) rate, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B).
extension phase
Measured: 48 months
CR and CR with incomplete hematologic recovery (CRi) rate, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B).
extension phase
Measured: 48 months
CR with partial hematologic recovery (CRh) rate, based on ELN 2022 recommendations.
extension phase
Measured: 48 months
CR and CR with partial hematologic recovery (CRh) rate, based on ELN 2022 recommendations.
extension phase
Measured: 48 months
CR or CR/CRi or CR/CRh without minimal residual disease (flow and or molecular) (CRMRD- or CR/CRiMRD- or CR/CRhMRD-).
extension phase
Measured: 48 months
Morphologic leukemia-free state (MLFS) rate, based on ELN2022 recommendations.
extension phase
Measured: 48 months
Event free survival (EFS).
extension phase
Measured: 48 months
Relapse-free survival (RFS).
extension phase
Measured: 48 months
Incidence and severity of adverse events according to CTCAE version 5.0.
extension phase
Measured: 48 months
Early (30-day and 60-day) mortality (in general, non-leukemic).
extension phase
Measured: 48 months
Time to next cycle, defined as the time from the start of the cycle until the start of the next cycle.
extension phase
Measured: 48 months
OS of AZA/VEN/COBI treated patients in comparison with a real-world data cohort treated during the same time period and monitored by the Dutch Cancer registry.
extension phase
Measured: 48 months
Prognostic/predictive impact of disease-associated genetic changes at diagnosis.
extension phase
Measured: 48 months
Relapse-associated genetic changes (determined at relapse). The average relative dose intensity will be computed and given by categories. The same will be done for treatment deviation.
extension phase
Measured: 48 months
Clonal evolution during treatment.
extension phase
Measured: 48 months
Exposure-response and exposure-toxicity relation of venetoclax in patients with AML.
extension phase
Measured: 48 months
Cost-savings on venetoclax drug costs.
extension phase
Measured: 48 months
Adherence to venetoclax and cobicistat.
extension phase
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start17 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AML, AdultStudies 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
- Sequential
- Model description
- the study consists of a run-in phase and an extension phase
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014489
- Sponsor's protocol ID
- HO171
- Other IDs
- 2023-505379-61-00, 2023
- Acronym
- HO171
- Status last verified
- Sep 2026
- First submitted
- 4 Jul 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Westra N, Cerro ER, Schilder E, Lub-de Hooge MN, Touw DJ, Kosterink JGW, Chitu DA, Ammatuna E, Klein SK, Westerweel PE, Cuijpers M, Cruijsen M, Corsten MMF, Alhan C, Tick L, Schuringa JJ, Huls G, Woolthuis CM, Oude Munnink TH. Pharmacological boosting of azacitidine/venetoclax in acute myeloid leukemia. Blood Neoplasia. 2026 Mar 12;3(2):100218. doi: 10.1016/j.bneo.2026.100218. eCollection 2026 May.
PubMed 42007248
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine (sc) in Adult Patients With Newly Diagnosed Acute Myeloid Leukaemia (AML) Who Are Not Considered Candidates for Intensive Treatment Regimens
- ClinicalTrials.gov ID
- NCT06014489
- Acronym / sponsor ID
- HO171 / HO171
- Conditions
- AML, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen NederlandUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Aug 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 treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the study consists of a run-in phase and an extension phase
| Arm | Type | Receives |
|---|---|---|
| single arm arm extension phase | Experimental | Drug: azacitidine, Drug: Venetoclax, Drug: Cobicistatprior to the extention phase, there is a run-in phase with (n= 20 patients of 142 total) with the same study scheme, except that cobicistat is added from cycle 2 onwards to the treatment instead of during cycle 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia) (appendix A). Patients may have had previous treatment with erythropoiesis stimulating agents (ESA) for an antecedent phase of MDS. ESAs must be stopped at least two weeks before registration.
- Patients 18 years and older who are considered not fit for intensive chemotherapy or who decline the option of intensive chemotherapy.
- WHO performance status 0, 1 or 2 (appendix E).
- Leukocytes < 30 x109/L
Key exclusion criteria (22 listed)
- Acute promyelocytic leukemia.
- Myelodysplastic syndrome (MDS).
- Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating agents (ESAs); 2) hydroxyurea ((previous treatment with hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis).
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion:
- Blast crisis of chronic myeloid leukemia.
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 |
|---|---|---|
| azacitidineduring run-in and extention phase: from Cycle 1 until relapse | Drug | single arm arm extension phase |
| Venetoclaxduring run-in and extention phase: from Cycle 1 until relapse | Drug | single arm arm extension phase |
| Cobicistatduring run-in phase: from cycle 2 until relapse during extension phase: from cycle 1 until relapse | Drug | single arm arm extension phase |
Primary outcome
Pharmacokinetic equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2).venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2).
Time frame: 6-8 months
run-in phase
Overall survival (OS).
Time frame: 48 months
extension phase
20 secondary outcomes
Venetoclax and cobicistat CL, Cmax, Tmax, Cmin and AUC0-24.
Time frame: 6-8 months
Complete remission (CR) rate defined as CR as best response during or at completion of the treatment, as determined by the Investigator, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B).
Time frame: 48 months
CR with incomplete hematologic recovery (CRi) rate, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B).
Time frame: 48 months
CR and CR with incomplete hematologic recovery (CRi) rate, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B).
Time frame: 48 months
CR with partial hematologic recovery (CRh) rate, based on ELN 2022 recommendations.
Time frame: 48 months
CR and CR with partial hematologic recovery (CRh) rate, based on ELN 2022 recommendations.
Time frame: 48 months
CR or CR/CRi or CR/CRh without minimal residual disease (flow and or molecular) (CRMRD- or CR/CRiMRD- or CR/CRhMRD-).
Time frame: 48 months
Morphologic leukemia-free state (MLFS) rate, based on ELN2022 recommendations.
Time frame: 48 months
Event free survival (EFS).
Time frame: 48 months
Relapse-free survival (RFS).
Time frame: 48 months
Incidence and severity of adverse events according to CTCAE version 5.0.
Time frame: 48 months
Early (30-day and 60-day) mortality (in general, non-leukemic).
Time frame: 48 months
Time to next cycle, defined as the time from the start of the cycle until the start of the next cycle.
Time frame: 48 months
OS of AZA/VEN/COBI treated patients in comparison with a real-world data cohort treated during the same time period and monitored by the Dutch Cancer registry.
Time frame: 48 months
Prognostic/predictive impact of disease-associated genetic changes at diagnosis.
Time frame: 48 months
Relapse-associated genetic changes (determined at relapse). The average relative dose intensity will be computed and given by categories. The same will be done for treatment deviation.
Time frame: 48 months
Clonal evolution during treatment.
Time frame: 48 months
Exposure-response and exposure-toxicity relation of venetoclax in patients with AML.
Time frame: 48 months
Cost-savings on venetoclax drug costs.
Time frame: 48 months
Adherence to venetoclax and cobicistat.
Time frame: 48 months
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 23 Sep 2026.
- Derived from this study: PubMed 42007248Westra N, Cerro ER, Schilder E, Lub-de Hooge MN, Touw DJ, Kosterink JGW, Chitu DA, Ammatuna E, Klein SK, Westerweel PE, Cuijpers M, Cruijsen M, Corsten MMF, Alhan C, Tick L, Schuringa JJ, Huls G, Woolthuis CM, Oude Munnink TH. Pharmacological boosting of azacitidine/venetoclax in acute myeloid leukemia. Blood Neoplasia. 2026 Mar 12;3(2):100218. doi: 10.1016/j.bneo.2026.100218. eCollection 2026 May.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing azacitidine, Venetoclax and Cobicistat in people with AML, Adult, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 19 sites in Netherlands.
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 14 inclusion and 22 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Netherlands. 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 Gerwin Huls, prof (+3150 361 2354, g.huls@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2).venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2). (time frame: 6-8 months). 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?
On the ClinicalTrials.gov record for NCT06014489, which also lists 1 linked publication.
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 23 Sep 2026.