The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
The purpose of this Phase I/II study is to investigate the safety and tolerability (Phase I) and the efficacy/clinical benefits (Phase II, proof-of-concept) of ARGX-110 in combination with standard doses of azacytidine (AZA) in subjects with previously untreated acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) who are eligible for AZA treatment.
A Phase I/II, Open-label, Dose-Escalating Study With a Proof of Concept Cohort to Evaluate the Safety, Tolerability and Efficacy of ARGX-110 in Combination With Azacytidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Signed ICF indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study
AML or high risk myelodysplastic syndrome (MDS) (according to 2016 World Health Organization (WHO) classification definition of ≥ 20% blasts) (bone marrow) unsuitable for intensive treatment (including stem cell transplantation) with a curative intent, but eligible to receive AZA treatment Note: Subjects can be rescreened if excluded based on the blast count previously
Age ≥ 18 years
Expected life expectancy ≥ 3 months, at the discretion of the investigator
ECOG performance status of 0, 1, or 2
Prior or concurrent malignancy, except for the following:
Adequately treated basal cell or squamous cell skin cancer,
Carcinoma in situ of the cervix,
Carcinoma in situ of the breast or
Incidental histological finding of Prostate cancer (TNM stage T1a or T1b), or
Any other cancer from which the subject has been disease-free for more than 2 years
Any previous AML or MDS chemo- or radiotherapy (with the exception of hydroxyurea/Litalir® for leukocyte control which should be discontinued by the first day of AZA, local radiation therapy, therapy for basal or squamous cell carcinoma of the skin)
Treatment with any investigational product within 4 weeks before the first administration of ARGX-110
Abnormal organ function defined as follows (any single parameter to fulfill condition):
aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN); or in case of liver infiltration by AML, AST and/or ALT > 5 x ULN
Alkaline phosphatase (AP) > 2.5 x ULN, or in case of liver infiltration by AML, AP > 5 x ULN
Serum (total) bilirubin > 1.5 x ULN; or in case of liver infiltration by AML, serum (total) bilirubin > 5 x ULN
Serum creatinine > 2.5 x ULN or GFR (MDRD) of < 40 mL/min for subjects with creatinine levels above the normal limit.
Use of immune-suppressive agents for the past 4 weeks before the first administration of ARGX-110 on Day -14. For regular use of systemic corticosteroids, subjects may only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days before the first administration of ARGX-110
Any known active or chronic infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus infection