Leukemia, Myeloid, AcutePhase 1/2NCT03030612
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
A Phase 1/2 study testing ARGX-110 and AZA in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by OncoVerity, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of ARGX-110 when administered at a RP2D level established in Phase I in combination with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- What is being tested?
- ARGX-110 and AZA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2016to Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study
- Acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) (according to 2016 World Health Organization [WHO] classification definition of greater than or equal to [>=] 20 percent [%] blasts) (bone marrow) unsuitable for intensive treatment (including stem cell transplantation) with a curative intent, but eligible to receive azacytidine (AZA) treatment
- Expected life expectancy >= 3 months, at the discretion of the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Women of childbearing potential having a negative serum pregnancy test at screening and within 48 hours before infusion of ARGX-110 on Day -14, and willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 3 months after the last study drug administration
Who cannot join
- Prior or concurrent malignancy, except for the following: (1) adequately treated basal cell or squamous cell skin cancer; (2) carcinoma in situ of the cervix; (3) carcinoma in situ of the breast; (4) incidental histological finding of Prostate cancer (Tumour, Node, Metastasis [TNM] stage T1a or T1b), or; (5) 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
- Any known active or chronic infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus infection
- Any other concurrent disease or medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France4 sites
Study site
Marseille
Study site
Paris
Study site
Pierre-Bénite
Study site
Toulouse
About this study
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)
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of ARGX-110 when administered at a RP2D level established in Phase I in combination with a standard dose of AZA (proof-of concept) by evaluating overall response rate (ORR) in Phase 2.
- Being tested
- ARGX-110, AZA
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-110Drug
Also called Cusatuzumab, JNJ-74494550
ARGX-110 will be administered intravenously.
AZADrug
AZA will be administered subcutaneously/intravenously.
| Study group | Role | What they receive |
|---|---|---|
| ARGX-110 with Azacytidine (AZA) | Experimental | Phase 1: Participants will receive loading dose of ARGX-110 1 milligram per kilogram (mg/kg) body weight (cohort 1), 3 mg/kg body weight (cohort 2), 10 mg/kg body weight (cohort 3) or 20 mg/kg body weight (cohort 4) administered intravenously (IV) in combination with AZA standard dose of 75 milligram per meter square (mg/m^2) body surface area (BSA) administered subcutaneously (SC) / intravenously (IV). Phase 2: Participants will receive loading dose of ARGX-110 IV at a recommended dose for Phase 2 (RP2D) level from phase 1 in combination with AZA standard dose of 75 mg/m^2 BSA, administered SC/IV as per local practice. Receives: Drug: ARGX-110; Drug: AZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants with Dose Limiting Toxicity (DLT)
DLTs will be defined as any of the following drug-related events: Any grade 3 or higher drug related non-hematological toxicity or; Grade 3 or higher IRRs or; inability to administer the next dose due to a drug-related adverse event or a delay of the administration of the next dose due to toxicities for more than 14 days despite adequate medication or; drug-related grade 4 febrile neutropenia or; drug-related grade 4 anemia which cannot be adequately treated.
Measured: Up to 3.6 years
Phase 2: Overall Response Rate (ORR)
ORR is defined as the sum of Complete remission (CR), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR) at the ARGX-110 RP2D level that was established in Phase 1 according to established response criteria for Acute myeloid leukemia (AML).
Measured: Up to 3.6 years
Secondary outcomes (28)
Phase 1 and Phase 2: Number of Participants with Adverse Events
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of ARGX-110
Cmax is the maximum observed concentration.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Trough Concentration (Ctrough) of ARGX-110
Ctrough is defined as the observed serum concentration before dosing or at the end of the dosing interval.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Area Under the Serum Concentration-Time Curve from Time Zero to Infinite (AUC[0-infinity]) of ARGX-110
AUC(0-infinity) is defined as area under the serum analyte concentration-time curve from time 0 to infinite time of ARGX-110.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCtau)
AUCtau is the area under the serum concentration-time curve during the dosing interval.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Apparent Volume of Distribution (Vd/F) of ARGX-110
Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Measured: Up to 3.6 years
Phase 1 and Phase 2: Total Systemic Clearance (CL) of ARGX-110
CL is the total systemic clearance of drug after intravenous (IV) administration.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Elimination Half-Life (t1/2) of ARGX-110
t1/2 is defined as the time measured for the serum concentration to decrease by 1 half of its original concentration.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Minimal Residual Disease (MRD) to ARGX-110
Minimal residual disease assessments will be performed on bone marrow aspirates and/or whole blood by flow cytometry.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Anti-drug Antibodies (ADA) to ARGX-110
Venous blood samples and bone marrow aspirate will be used to evaluate presence of anti-drug antibodies to ARGX-110. Participants with titer of confirmed positive samples for ARGX-110 antibodies will be reported.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Complete Remission (CR)
Complete remission is defined as number of participants who have bone marrow blasts less than (<) 5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>) 1.0 * 10^9 per liter (L) (1000 per microliter [µL]); platelet count > 100 * 10^9/L (100.000/mc); independence of red cell transfusions.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with CR with Incomplete Recovery (CRi)
CRi is defined as number of participants who have all CR criteria except for residual neutropenia (< 1.0 * 10^9/L [1000/mc]) or thrombocytopenia (< 100 * 10^9/L [100.000/mc]).
Measured: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Morphologic Leukemia-free State (MLFS)
MLFS is defined as number of participants who have bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Partial remission (PR)
PR is defined as number of participants who have all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Time to Response
Time to response is defined as response measured from the time from first dose of study drug to date of response (CR, CRi, MLFS, PR).
Measured: Up to 3.6 years
Phase 1 and Phase 2: Duration of Response
Duration of response is defined as the date of achievement of a response (CR, CRi, MLFS, PR) until the date of relapse.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Relapse-Free Survival (RFS)
RFS is defined as disease relapse or participant death from any cause; measured from the date of achievement of a remission (CR, CRi) until the date of relapse or death from any cause.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Overall Survival (OS)
OS is defined as death from any cause; measured from the date of first dose to the date of death from any cause.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with 30 Day and 60 Day Mortality
Number of participants with 30 Day and 60 Day Mortality will be reported.
Measured: 30 and/or 60 days after the first administration
Phase 1 and Phase 2: Number of Participants Achieving Transfusion Independence (TI)
Number of participants reaching greater than or equal to (>=) 8 consecutive weeks without red blood cell (RBC-TI) and/or platelet (PLT-TI) transfusion. The first day of the >=8-week period with no transfusions is noted as the time at which participants first achieved TI.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Time to Transfusion Independence
Time until TI for RBC and/or PLT will be measured from the date of entry into a study to the first day of the 8-weeks period with no transfusions.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Duration of Transfusion Independence
Time between the last transfusion before the start of the TI period and the first transfusion after the start of the TI period, which occurred >=8 weeks later.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Time to Neutrophil Recovery
Time to neutrophil recovery will be calculated from number of days from Day 1 of commencing study treatment to first day neutrophils 0.5 * 10^9 per liter or 1.0 * 10^9 per liter.
Measured: Up to 3.6 years
Phase 1 and Phase 2: Time to Platelet Recovery
Time to platelet recovery will be calculated from number of days from day 1 of commencing study treatment to first day neutrophils 50 * 10^9 per liter or 100 * 10^9 per liter.
Measured: Up to 3.6 years
Biomarker Assessment of ARGX-110
Biomarkers including CD70 and CD27 assessment will be performed on bone marrow aspirates and/or whole blood.
Measured: Up to 3.6 years
Phase 1: Levels of T, B and NK Cells
Levels of T, B and NK cells will be reported by immunophenotyping (performed by flow cytometry or mass cytometry). .
Measured: Up to 3.6 years
Phase 1: Levels of B Cells
Levels of B cells will be reported.
Measured: Up to 3.6 years
Phase 1: Levels of NK Cells
Levels of NK cells will be reported.
Measured: Up to 3.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionAug 2022
- Study completionAug 2022
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 Leukemia, Myeloid, AcuteStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoVerity, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- argenx, Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030612
- Sponsor's protocol ID
- CR108756
- Other IDs
- 2016-002151-17, ARGX-110-1601, 2016
- Status last verified
- Aug 2023
- First submitted
- 23 Jan 2017
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Riether C, Pabst T, Hopner S, Bacher U, Hinterbrandner M, Banz Y, Muller R, Manz MG, Gharib WH, Francisco D, Bruggmann R, van Rompaey L, Moshir M, Delahaye T, Gandini D, Erzeel E, Hultberg A, Fung S, de Haard H, Leupin N, Ochsenbein AF. Targeting CD70 with cusatuzumab eliminates acute myeloid leukemia stem cells in patients treated with hypomethylating agents. Nat Med. 2020 Sep;26(9):1459-1467. doi: 10.1038/s41591-020-0910-8. Epub 2020 Jun 29.
PubMed 32601337
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03030612
- Acronym / sponsor ID
- CR108756
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- OncoVerity, Inc.Industry (pharma, biotech, devices)
- Collaborators
- argenx, Janssen Research & Development, LLC
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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 purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of ARGX-110 when administered at a RP2D level established in Phase I in combination with a standard dose of AZA (proof-of concept) by evaluating overall response rate (ORR) in Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARGX-110 with Azacytidine (AZA) | Experimental | Drug: ARGX-110, Drug: AZAPhase 1: Participants will receive loading dose of ARGX-110 1 milligram per kilogram (mg/kg) body weight (cohort 1), 3 mg/kg body weight (cohort 2), 10 mg/kg body weight (cohort 3) or 20 mg/kg body weight (cohort 4) administered intravenously (IV) in combination with AZA standard dose of 75 milligram per meter square (mg/m^2) body surface area (BSA) administered subcutaneously (SC) / intravenously (IV). Phase 2: Participants will receive loading dose of ARGX-110 IV at a recommended dose for Phase 2 (RP2D) level from phase 1 in combination with AZA standard dose of 75 mg/m^2 BSA, administered SC/IV as per local practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study
- Acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) (according to 2016 World Health Organization [WHO] classification definition of greater than or equal to [>=] 20 percent [%] blasts) (bone marrow) unsuitable for intensive treatment (including stem cell transplantation) with a curative intent, but eligible to receive azacytidine (AZA) treatment
- Expected life expectancy >= 3 months, at the discretion of the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Women of childbearing potential having a negative serum pregnancy test at screening and within 48 hours before infusion of ARGX-110 on Day -14, and willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 3 months after the last study drug administration
Key exclusion criteria (5 listed)
- Prior or concurrent malignancy, except for the following: (1) adequately treated basal cell or squamous cell skin cancer; (2) carcinoma in situ of the cervix; (3) carcinoma in situ of the breast; (4) incidental histological finding of Prostate cancer (Tumour, Node, Metastasis [TNM] stage T1a or T1b), or; (5) 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
- Any known active or chronic infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus infection
- Any other concurrent disease or medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
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 |
|---|---|---|
| ARGX-110Also: Cusatuzumab, JNJ-74494550ARGX-110 will be administered intravenously. | Drug | ARGX-110 with Azacytidine (AZA) |
| AZAAZA will be administered subcutaneously/intravenously. | Drug | ARGX-110 with Azacytidine (AZA) |
Primary outcome
Phase 1: Number of Participants with Dose Limiting Toxicity (DLT)
Time frame: Up to 3.6 years
DLTs will be defined as any of the following drug-related events: Any grade 3 or higher drug related non-hematological toxicity or; Grade 3 or higher IRRs or; inability to administer the next dose due to a drug-related adverse event or a delay of the administration of the next dose due to toxicities for more than 14 days despite adequate medication or; drug-related grade 4 febrile neutropenia or; drug-related grade 4 anemia which cannot be adequately treated.
Phase 2: Overall Response Rate (ORR)
Time frame: Up to 3.6 years
ORR is defined as the sum of Complete remission (CR), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR) at the ARGX-110 RP2D level that was established in Phase 1 according to established response criteria for Acute myeloid leukemia (AML).
28 secondary outcomes
Phase 1 and Phase 2: Number of Participants with Adverse Events
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Trough Concentration (Ctrough) of ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Area Under the Serum Concentration-Time Curve from Time Zero to Infinite (AUC[0-infinity]) of ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCtau)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Apparent Volume of Distribution (Vd/F) of ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Total Systemic Clearance (CL) of ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Elimination Half-Life (t1/2) of ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Minimal Residual Disease (MRD) to ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Anti-drug Antibodies (ADA) to ARGX-110
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Complete Remission (CR)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with CR with Incomplete Recovery (CRi)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Morphologic Leukemia-free State (MLFS)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with Partial remission (PR)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Time to Response
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Duration of Response
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Relapse-Free Survival (RFS)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Overall Survival (OS)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Number of Participants with 30 Day and 60 Day Mortality
Time frame: 30 and/or 60 days after the first administration
Phase 1 and Phase 2: Number of Participants Achieving Transfusion Independence (TI)
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Time to Transfusion Independence
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Duration of Transfusion Independence
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Time to Neutrophil Recovery
Time frame: Up to 3.6 years
Phase 1 and Phase 2: Time to Platelet Recovery
Time frame: Up to 3.6 years
Biomarker Assessment of ARGX-110
Time frame: Up to 3.6 years
Phase 1: Levels of T, B and NK Cells
Time frame: Up to 3.6 years
Phase 1: Levels of B Cells
Time frame: Up to 3.6 years
Phase 1: Levels of NK Cells
Time frame: Up to 3.6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 32601337Riether C, Pabst T, Hopner S, Bacher U, Hinterbrandner M, Banz Y, Muller R, Manz MG, Gharib WH, Francisco D, Bruggmann R, van Rompaey L, Moshir M, Delahaye T, Gandini D, Erzeel E, Hultberg A, Fung S, de Haard H, Leupin N, Ochsenbein AF. Targeting CD70 with cusatuzumab eliminates acute myeloid leukemia stem cells in patients treated with hypomethylating agents. Nat Med. 2020 Sep;26(9):1459-1467. doi: 10.1038/s41591-020-0910-8. Epub 2020 Jun 29.
- 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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ARGX-110 and AZA in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by OncoVerity, Inc. at 7 sites in 2 countries.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Switzerland. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of Participants with Dose Limiting Toxicity (DLT) (time frame: Up to 3.6 years). 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 NCT03030612, 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 9 Aug 2023.