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ARGX-110 With AZA in AML or High Risk MDS

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ClinicalTrials.gov Identifier: NCT03030612
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
argenx BVBA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia High Risk Myelodysplastic Syndrome Drug: ARGX-110 with AZA Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 : December 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: ARGX-110 with AZA

Phase I:

  • ARGX-110: 1 mg/kg body weight IV (cohort 1), 3 mg/kg body weight IV (cohort 2), 10 mg/kg body weight IV (cohort 3) or 20 mg/kg body weight IV (cohort 4) in combination with
  • AZA standard dose of 75 mg/m² BSA , administered SC

Phase 2:

  • ARGX-110: selected dose from Phase I, IV, in combination with
  • AZA standard dose of 75 mg/m² BSA , administered subcutaneously (SC)/intravenously (IV), as per local practice
Drug: ARGX-110 with AZA



Primary Outcome Measures :
  1. Incidence rate of DLT at each dose level [ Time Frame: 18 months ]
  2. Overall Response Rate (ORR) [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed ICF indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study
  2. 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
  3. Age ≥ 18 years
  4. Expected life expectancy ≥ 3 months, at the discretion of the investigator
  5. ECOG performance status of 0, 1, or 2

Exclusion Criteria:

  1. 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
  2. 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)
  3. Treatment with any investigational product within 4 weeks before the first administration of ARGX-110
  4. 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.
  5. 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
  6. Any known active or chronic infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030612


Locations
France
Recruiting
Marseille, France
Contact: Norbert Vey, Prof.       VEYN@ipc.unicancer.fr   
Recruiting
Pierre-Bénite, France
Contact: Xavier Thomas, Dr.       xavier.thomas@chu-lyon.fr   
Recruiting
Toulouse, France
Contact: Christian Recher, Prof.       recher.christian@iuct-oncopole.fr   
Italy
Recruiting
Novara, Italy
Contact: Gianluca GAIDANO, Prof       'gianluca.gaidano@med.uniupo.it   
Switzerland
Kantonsspital Aarau (University Clinic for Medicine, Center of Oncology/Hematology and Transfusion Medicine) Recruiting
Aarau, Switzerland
Contact: Mario Bargetzi, Prof. Dr.       Mario.Bargetzi@ksa.ch   
Inselspital/University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Thomas Pabst, Prof. dr.       Thomas.PabstMueller@insel.ch   
UniversitätsSpital Recruiting
Zürich, Switzerland
Contact: Rouven Müller, dr.       Rouven.Mueller@usz.ch   
Sponsors and Collaborators
argenx BVBA

Responsible Party: argenx BVBA
ClinicalTrials.gov Identifier: NCT03030612     History of Changes
Other Study ID Numbers: ARGX-110-1601
2016-002151-17 ( EudraCT Number )
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions