Back to resultsA Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
Primary Purpose
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Azacitidine
Cusatuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of de novo or secondary higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) per World Health Organization (WHO) 2016 criteria
- At study entry, higher-risk MDS (intermediate, high, and very high risk MDS per Revised International Prognostic Scoring System [IPSS R]) OR higher-risk CMML (intermediate-2 or high risk CMML per CMML-specific Prognostic Scoring System [CPSS-Mol]). Participants with previous lower-risk MDS or CMML that has evolved to higher-risk MDS or CMML are eligible
- At study entry, not a candidate for Hematopoietic Stem Cell Transplantation (HSCT)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Adequate liver and renal function defined as follows: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than (<) 3 * upper limit of normal (ULN); Total bilirubin less than or equal to (<=) 1.5 * ULN, unless bilirubin rise is due to Gilbert's syndrome or of non hepatic origin; and Creatinine clearance (CrCl) greater than (>) 30 milliliter per minute per 1.73 square meters (mL/min/1.73 m^2) (by Modification of Diet in Renal Disease formula)
Exclusion Criteria:
- Received prior HSCT or any prior treatment, including hypomethylating agent (HMAs), for higher-risk MDS or CMML. Prior supportive therapies including transfusion and growth factors are acceptable
- Received prior treatment with cusatuzumab
- Presence of the breakpoint cluster region protein-Abelson murine leukemia (bcr-abl) rearrangement
- Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
- Any active systemic infection
Sites / Locations
- St Vincents Hospital Sydney
- St Vincents Hospital Melbourne
- Peter MacCallum Cancer Institute
- Royal Perth Hospital
- Westmead Hospital
- Wollongong Hospital
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer
- Cepon - Centro De Pesquisas Oncologicas
- Liga Norte Riograndense Contra O Cancer
- Hospital de Clínicas de Porto Alegre
- Instituto do cancer -COR -Hospital Mae de Deus
- Oncoclínicas
- Hospital de Base de São José do Rio Preto
- Hospital Paulistano
- Instituto D'Or de Pesquisa e Ensino (IDOR)
- CHU d'Angers
- Hopital Saint Vincent de Paul
- CHU de Limoges, Hopital Dupuytren
- Hôpital de La Conception
- CHU de Nice Hopital de l Archet
- Hopital Saint-Louis
- Hopital Cochin APHP
- CHRU Tours Hôpital Bretonneau
- CHU de Nancy_ Hôpital Brabois
- Universitatsklinikum Carl Gustav Carcus Dresden
- Universitätsklinik Freiburg
- Medizinische Hochschule Hannover
- Universitatsklinikum Leipzig
- Klinikum rechts der Isar an der Technischen Universität München
- Universitaetsklinikum Ulm
- Policlinico Sant'Orsola Malpighi
- Azienda Ospedaliero Universitaria di Ferrara
- Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
- Aou San Luigi Gonzaga
- Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
- Fondazione Policlinico Tor Vergata
- Policlinico Umberto I
- Istituto Clinico Humanitas
- Emergency Hospital of Dzerzhinsk
- S.P. Botkin Moscow City Clinical Hospital
- Nizhniy Novgorod Region Clinical Hospital
- Ryazan Regional Clinical Hospital
- Saint Petersburg City Hospital #15
- Clinical Research Institute of Hematology and Transfusiology
- St.-Petersburg City Clinical Hospital nr 31
- Oncology Dispensary of Komi Republic
- King Fahad Specialist hospital
- King Abdulaziz Medical City
- King Faisal Specialist Hospital & Research Center
- Hosp. Univ. Germans Trias I Pujol
- Hosp. Univ. Vall D Hebron
- Hosp. de La Santa Creu I Sant Pau
- Inst. Cat. Doncologia-H Duran I Reynals
- Hosp. Univ. Infanta Leonor
- Centro Integral Oncológico Clara Campal
- Hosp. Univ. Son Espases
- Hosp. Clinico Univ. de Salamanca
- Hosp. Virgen Del Rocio
- INSELSPITAL, Universitätsspital Bern
- Hopitaux Universitaires de Geneve
- UniversitaetsSpital Zuerich
- Gulhane Egitim ve Arastirma Hastanesi
- Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
- Ankara Universitesi Tip Fakultesi
- Koc Universitesi Hastanesi
- Ege Universitesi Tip Fakultesi
- Dokuz Eylul Universitesi Tip Fakultesi
- Ondokuz Mayis Universitesi Tip Fakultesi
- St James Hospital
- University College London Hospitals
- Kings College Hospital
- Royal Victoria Infirmary
- Churchill Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Azacitidine: Participants with MDS or CMML
Azacitidine and Cusatuzumab: Participants with MDS or CMML
Arm Description
Participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) will receive azacitidine 75 milligram per meter square (mg/m^2) body surface area (BSA) subcutaneously or Intravenously per local label on Days 1 through Day 7 of each 28-day cycle. Participants will be treated until disease progression; relapse from complete remission (CR), partial remission (PR), or marrow complete remission (mCR); transformation to acute myeloid leukemia (AML); death; or unacceptable toxicity.
Participants with higher-risk MDS or CMML will receive azacitidine 75 mg/m^2 BSA subcutaneously or Intravenously per local label on Days 1 through 7 and cusatuzumab 20 mg/kg IV on Days 3 and 17 of each 28-day cycle. Participants will be treated until disease progression; relapse from CR, PR, mCR; transformation to AML; death; or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
ORR is a composite of complete remission (CR), partial remission (PR) and marrow complete remission (mCR) as per modified International Working Group (IWG) criteria.
Secondary Outcome Measures
Percentage of Participants Achieving Complete Remission (CR)
Percentage of participants achieving CR as per IWG criteria will be reported.
Percentage of Participants who Achieve Transfusion Independence
Percentage of participants who achieve transfusion independence will be reported. Transfusion independence is defined as a period of greater than or equal to (>=) 56 consecutive days with no transfusion occurring between the first and last dose of study drug +30 days.
Time to Transformation of Participants to Acute Myeloid Leukemia (AML)
Time to transformation of participants to AML will be reported. Transformation to AML is defined as >= 20% bone marrow blasts.
Progression Free Survival (PFS)
PFS is defined as the time from randomization to disease progression; relapse from CR, PR, or mCR; or death from any cause.
Overall Survival (OS)
OS is defined as the time from randomization to death.
Hematologic Improvement Rate
Hematologic improvement rate is defined as erythroid response (pretreatment, less than (<) 11 g/dL; hemoglobin >= 1.5 g/dL; relevant reduction of units of RBC transfusions by an absolute number of >= 4 Red blood cell (RBC) transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation; platelet response (pretreatment <100*10^9/L); absolute increase of >= 30*109/L for participants starting with >20*10^9/L platelets; increase to >20*109/L and by >= 100% for participants starting with <= 20*109/L platelets; Neutrophil response (pretreatment <1.0×10^9/L); and at least 100% increase and an absolute increase of >0.5*10^9/L.
Percentage of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An adverse event 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.
Percentage of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Percentage of participants with clinically significant abnormalities in laboratory parameters will be reported.
Area Under the Serum Concentration-Time Curve Within Timespan t1 to t2 (AUC[t1-t2]) of Cusatuzumab
The AUC(t1-t2) is the area under the serum concentration-time curve within timespan t1 to t2.
Maximum Serum Concentration (Cmax) of Cusatuzumab
Cmax is the maximum observed serum concentration.
Minimum Serum Concentration (Cmin) of Cusatuzumab
Cmin is the minimum observed serum concentration.
Elimination Half-Life (t1/2) of Cusatuzumab
T1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Systemic Clearance (CL) of Cusatuzumab
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Volume of Distribution (Vz) of Cusatuzumab
The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Number of Participants with Developed Antidrug Antibodies to Cusatuzumab
Venous blood samples are analyzed for presence of antidrug antibodies to cusatuzumab. Participants with titer of confirmed positive samples for cusatuzumab antibodies are reported.
Percentage of Participants Achieving Complete Remission (CR) and Partial Remission (PR)
Percentage of participants achieving CR and PR as per IWG criteria will be reported.
Time to response
Time to response for participants who achieved CR, PR and mCR responses, defined as time from randomization to achieving the first response of CR, PR, or mCR as per modified IWG criteria.
Duration of response
Time from achieving the first response of CR, PR, or mCR to relapse or death from any cause for those participants who responded.
Percentage of Participants With Clinically Meaningful Improvement in Functional Assessment of Cancer Therapy - Anemia Trial Outcome Index (FACT-An TOI) Total Score
FACT-An is a scale in Functional Assessment of Chronic Illness Therapy Measurement System. It consists of Functional Assessment of Cancer Therapy (general version; FACT-G) and 20 questions labeled "additional concerns" that measure anemia/fatigue. FACT-G is 27-item compilation of general questions divided into 4 primary quality of life domains: physical well-being, social/family well-being, emotional wellbeing, and functional well-being. Participants will be asked to rate scale items as it applies to past 7 days, on 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). Negatively stated items will be reversed by subtracting the response from 4. After reversing the proper items, items are summed to a total to generate a score on (sub)scale. A summary Trial Outcome Index total score (FACT An TOI) will be calculated by summing physical well being, functional well being, and anemia symptoms subscales and higher is the score better is the quality of life.
Full Information
NCT ID
NCT04264806
First Posted
February 7, 2020
Last Updated
May 19, 2022
Sponsor
Janssen Research & Development, LLC
Collaborators
argenx
1. Study Identification
Unique Protocol Identification Number
NCT04264806
Brief Title
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
Official Title
A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The cusatuzumab MDS strategy is under revision
Study Start Date
May 6, 2021 (Anticipated)
Primary Completion Date
April 19, 2022 (Anticipated)
Study Completion Date
January 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
argenx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).
Detailed Description
Cusatuzumab (also known as JNJ-74494550 and ARGX-110) is a humanized monoclonal antibody of camelid origin that binds with high affinity to human Cluster of Differentiation 70 (CD70). Azacitidine (an Hypomethylating agent [HMA]) is approved for the treatment of higher-risk MDS in the United States (US) and the European Union (EU). Both approvals are based on data showing decreased transfusion burden, delayed progression to acute myeloid leukemia (AML), improved quality of life, and extended survival. It is hypothesized that the addition of cusatuzumab to azacitidine will result in an improvement in overall response rate (ORR) compared with azacitidine alone in participants with higher-risk MDS or CMML.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azacitidine: Participants with MDS or CMML
Arm Type
Experimental
Arm Description
Participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) will receive azacitidine 75 milligram per meter square (mg/m^2) body surface area (BSA) subcutaneously or Intravenously per local label on Days 1 through Day 7 of each 28-day cycle. Participants will be treated until disease progression; relapse from complete remission (CR), partial remission (PR), or marrow complete remission (mCR); transformation to acute myeloid leukemia (AML); death; or unacceptable toxicity.
Arm Title
Azacitidine and Cusatuzumab: Participants with MDS or CMML
Arm Type
Experimental
Arm Description
Participants with higher-risk MDS or CMML will receive azacitidine 75 mg/m^2 BSA subcutaneously or Intravenously per local label on Days 1 through 7 and cusatuzumab 20 mg/kg IV on Days 3 and 17 of each 28-day cycle. Participants will be treated until disease progression; relapse from CR, PR, mCR; transformation to AML; death; or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Participants will receive subcutaneous (SC) or intravenous (IV) injection of Azacitidine 75 mg/m^2.
Intervention Type
Drug
Intervention Name(s)
Cusatuzumab
Other Intervention Name(s)
JNJ-74494550,, ARGX-110
Intervention Description
Participants will receive SC or IV injection of Cusatuzumab 20 mg/kg.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is a composite of complete remission (CR), partial remission (PR) and marrow complete remission (mCR) as per modified International Working Group (IWG) criteria.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Complete Remission (CR)
Description
Percentage of participants achieving CR as per IWG criteria will be reported.
Time Frame
Up to 4 years
Title
Percentage of Participants who Achieve Transfusion Independence
Description
Percentage of participants who achieve transfusion independence will be reported. Transfusion independence is defined as a period of greater than or equal to (>=) 56 consecutive days with no transfusion occurring between the first and last dose of study drug +30 days.
Time Frame
Up to 4 years
Title
Time to Transformation of Participants to Acute Myeloid Leukemia (AML)
Description
Time to transformation of participants to AML will be reported. Transformation to AML is defined as >= 20% bone marrow blasts.
Time Frame
Up to 4 years
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from randomization to disease progression; relapse from CR, PR, or mCR; or death from any cause.
Time Frame
Up to 4 years
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death.
Time Frame
Up to 4 years
Title
Hematologic Improvement Rate
Description
Hematologic improvement rate is defined as erythroid response (pretreatment, less than (<) 11 g/dL; hemoglobin >= 1.5 g/dL; relevant reduction of units of RBC transfusions by an absolute number of >= 4 Red blood cell (RBC) transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation; platelet response (pretreatment <100*10^9/L); absolute increase of >= 30*109/L for participants starting with >20*10^9/L platelets; increase to >20*109/L and by >= 100% for participants starting with <= 20*109/L platelets; Neutrophil response (pretreatment <1.0×10^9/L); and at least 100% increase and an absolute increase of >0.5*10^9/L.
Time Frame
Up to 4 years
Title
Percentage of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
An adverse event 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.
Time Frame
Up to 4 years
Title
Percentage of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Description
Percentage of participants with clinically significant abnormalities in laboratory parameters will be reported.
Time Frame
Up to 4 years
Title
Area Under the Serum Concentration-Time Curve Within Timespan t1 to t2 (AUC[t1-t2]) of Cusatuzumab
Description
The AUC(t1-t2) is the area under the serum concentration-time curve within timespan t1 to t2.
Time Frame
Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
Title
Maximum Serum Concentration (Cmax) of Cusatuzumab
Description
Cmax is the maximum observed serum concentration.
Time Frame
Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
Title
Minimum Serum Concentration (Cmin) of Cusatuzumab
Description
Cmin is the minimum observed serum concentration.
Time Frame
Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
Title
Elimination Half-Life (t1/2) of Cusatuzumab
Description
T1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Time Frame
Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
Title
Systemic Clearance (CL) of Cusatuzumab
Description
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame
Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
Title
Volume of Distribution (Vz) of Cusatuzumab
Description
The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame
Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years])
Title
Number of Participants with Developed Antidrug Antibodies to Cusatuzumab
Description
Venous blood samples are analyzed for presence of antidrug antibodies to cusatuzumab. Participants with titer of confirmed positive samples for cusatuzumab antibodies are reported.
Time Frame
Cycle 1: Day 3 (Predose); Cycle 1: Day 17 (Predose); Cycle 2: Day 3 (Predose); Cycle 8 and 11: Day 3 (Predose) and EOT (up to 4 years)
Title
Percentage of Participants Achieving Complete Remission (CR) and Partial Remission (PR)
Description
Percentage of participants achieving CR and PR as per IWG criteria will be reported.
Time Frame
Up to 4 years
Title
Time to response
Description
Time to response for participants who achieved CR, PR and mCR responses, defined as time from randomization to achieving the first response of CR, PR, or mCR as per modified IWG criteria.
Time Frame
Up to 4 years
Title
Duration of response
Description
Time from achieving the first response of CR, PR, or mCR to relapse or death from any cause for those participants who responded.
Time Frame
Up to 4 years
Title
Percentage of Participants With Clinically Meaningful Improvement in Functional Assessment of Cancer Therapy - Anemia Trial Outcome Index (FACT-An TOI) Total Score
Description
FACT-An is a scale in Functional Assessment of Chronic Illness Therapy Measurement System. It consists of Functional Assessment of Cancer Therapy (general version; FACT-G) and 20 questions labeled "additional concerns" that measure anemia/fatigue. FACT-G is 27-item compilation of general questions divided into 4 primary quality of life domains: physical well-being, social/family well-being, emotional wellbeing, and functional well-being. Participants will be asked to rate scale items as it applies to past 7 days, on 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). Negatively stated items will be reversed by subtracting the response from 4. After reversing the proper items, items are summed to a total to generate a score on (sub)scale. A summary Trial Outcome Index total score (FACT An TOI) will be calculated by summing physical well being, functional well being, and anemia symptoms subscales and higher is the score better is the quality of life.
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of de novo or secondary higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) per World Health Organization (WHO) 2016 criteria
At study entry, higher-risk MDS (intermediate, high, and very high risk MDS per Revised International Prognostic Scoring System [IPSS R]) OR higher-risk CMML (intermediate-2 or high risk CMML per CMML-specific Prognostic Scoring System [CPSS-Mol]). Participants with previous lower-risk MDS or CMML that has evolved to higher-risk MDS or CMML are eligible
At study entry, not a candidate for Hematopoietic Stem Cell Transplantation (HSCT)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Adequate liver and renal function defined as follows: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than (<) 3 * upper limit of normal (ULN); Total bilirubin less than or equal to (<=) 1.5 * ULN, unless bilirubin rise is due to Gilbert's syndrome or of non hepatic origin; and Creatinine clearance (CrCl) greater than (>) 30 milliliter per minute per 1.73 square meters (mL/min/1.73 m^2) (by Modification of Diet in Renal Disease formula)
Exclusion Criteria:
Received prior HSCT or any prior treatment, including hypomethylating agent (HMAs), for higher-risk MDS or CMML. Prior supportive therapies including transfusion and growth factors are acceptable
Received prior treatment with cusatuzumab
Presence of the breakpoint cluster region protein-Abelson murine leukemia (bcr-abl) rearrangement
Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
Any active systemic infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical trials
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
St Vincents Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Melbourne
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Wollongong Hospital
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Facility Name
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Cepon - Centro De Pesquisas Oncologicas
City
Florianopolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59062-000
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Instituto do cancer -COR -Hospital Mae de Deus
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Oncoclínicas
City
Rio De Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Hospital de Base de São José do Rio Preto
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Paulistano
City
São Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
São Paulo
ZIP/Postal Code
4501000
Country
Brazil
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Saint Vincent de Paul
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHU de Limoges, Hopital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital de La Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU de Nice Hopital de l Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Saint-Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Cochin APHP
City
Paris, 75
ZIP/Postal Code
75674
Country
France
Facility Name
CHRU Tours Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CHU de Nancy_ Hôpital Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Universitatsklinikum Carl Gustav Carcus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinik Freiburg
City
Freiburg Im Breisgau
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum rechts der Isar an der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Ferrara
City
Cona
ZIP/Postal Code
44124
Country
Italy
Facility Name
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Aou San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
Fondazione Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Emergency Hospital of Dzerzhinsk
City
Dzerzhinsk
ZIP/Postal Code
606019
Country
Russian Federation
Facility Name
S.P. Botkin Moscow City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Nizhniy Novgorod Region Clinical Hospital
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Saint Petersburg City Hospital #15
City
Saint-Petersburg
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Clinical Research Institute of Hematology and Transfusiology
City
St-Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
St.-Petersburg City Clinical Hospital nr 31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Oncology Dispensary of Komi Republic
City
Syktyvkar
ZIP/Postal Code
167904
Country
Russian Federation
Facility Name
King Fahad Specialist hospital
City
Dammam
ZIP/Postal Code
15215
Country
Saudi Arabia
Facility Name
King Abdulaziz Medical City
City
Jeddah
ZIP/Postal Code
21423
Country
Saudi Arabia
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Inst. Cat. Doncologia-H Duran I Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hosp. Univ. Son Espases
City
Palma
ZIP/Postal Code
7120
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
INSELSPITAL, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zürich
Country
Switzerland
Facility Name
Gulhane Egitim ve Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Koc Universitesi Hastanesi
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
St James Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RF
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upun Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
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