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A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML

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

NCT06014489•Stichting Hemato-Oncologie voor Volwassenen Nederland

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).
•Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
•* 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.
+3 more criteria

Exclusion Criteria

•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 (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;
•* 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:
+12 more criteria

Locations (18)

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

NL-Amsterdam-OLVG

Amsterdam, Netherlands

NL-Amsterdam-VUMC

Amsterdam, Netherlands

NL-Arnhem-RIJNSTATE

Arnhem, Netherlands

NL-Breda-AMPHIA

Breda, Netherlands

NL-Dordrecht-ASZ

Dordrecht, Netherlands

NL-Eindhoven-CATHARINA

Eindhoven, Netherlands

NL-Eindhoven-MAXIMAMC

Eindhoven, Netherlands

NL-Enschede-MST

Enschede, Netherlands

NL-Groningen-UMCG

Groningen, Netherlands

Key Dates

Start Date

January 17, 2024

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

January 18, 2024

Enrollment

142

ESTIMATED participants

Conditions

AML, Adult

Interventions

azacitidine

DRUG

Venetoclax

DRUG

Cobicistat

DRUG

Contacts

Gerwin Huls, prof

CONTACT

+3150 361 2354 g.huls@umcg.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML

Inclusion Criteria

Exclusion Criteria

Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

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