Condition or disease | Intervention/treatment | Phase |
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Leukemia, Myeloid, Acute | Drug: Azacitidine Drug: Cusatuzumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy |
Actual Study Start Date : | July 29, 2019 |
Estimated Primary Completion Date : | March 31, 2022 |
Estimated Study Completion Date : | March 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Azacitidine 75 mg/m^2 and Cusatuzumab 10 mg/kg
Participants will receive azacitidine 75 milligram per meter square (mg/m^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee.
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Drug: Azacitidine
Azacitidine SC or IV will be administered at a standard dose of 75 mg/m^2 on days 1-7 of each cycle.
Drug: Cusatuzumab Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.
Other Name: JNJ-74494550
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Experimental: Azacitidine 75 mg/m^2 and Cusatuzumab 20 mg/kg
Participants will receive azacitidine 75 mg/m^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee.
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Drug: Azacitidine
Azacitidine SC or IV will be administered at a standard dose of 75 mg/m^2 on days 1-7 of each cycle.
Drug: Cusatuzumab Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.
Other Name: JNJ-74494550
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acute myeloid leukemia (AML) according to World Health Organisation (WHO) 2016 criteria and fulfilling all of the following criteria that defines those who are "not candidates for intensive chemotherapy":
Exclusion Criteria:
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 16, 2019 | ||||||
First Posted Date ICMJE | July 17, 2019 | ||||||
Last Update Posted Date | April 23, 2021 | ||||||
Actual Study Start Date ICMJE | July 29, 2019 | ||||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Percentage of Participants with Complete Response (CR) [ Time Frame: Up to 1.5 years ] Percentage of participants with complete response based on European Leukemia Network (ELN) 2017 response criteria assessment will be reported.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy | ||||||
Official Title ICMJE | A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy | ||||||
Brief Summary | The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. | ||||||
Detailed Description | AML is a heterogeneous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells. As the most common form of acute leukemia, AML accounts for the largest number of annual deaths from leukemia. Over 95 percent (%) of AML blasts harvested from newly diagnosed AML participants expressed Cluster of Differentiation (CD) 70 on the cell surface. Cusatuzumab (JNJ-74494550) is a humanized monoclonal antibody of camelid origin, binding with tight affinity to human CD70. Cusatuzumab has been modified to induce enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) for therapeutic use in participants with cancer. Azacitidine is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity and is indicated for the treatment of adult participants with AML or intermediate 2 and high-risk myelodysplastic syndrome (MDS) with greater than 20% marrow blasts who are not eligible for hematopoietic stem cell transplantation. This study will evaluate 2 doses of cusatuzumab in combination with standard dose azacitidine in participants with AML who are not candidates for intensive chemotherapy (Part 1). Part 1 data will be reviewed by a Data Review Committee to select a preferred dose of cusatuzumab. The study will include a Screening Phase (28 days prior to randomization), a Treatment Phase, and a Follow-up Phase. The study includes evaluations like vital signs, electrocardiogram, spirometry test, serum chemistry and hematology tests. The study will be conducted for an approximate duration of 2 years. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukemia, Myeloid, Acute | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
103 | ||||||
Original Estimated Enrollment ICMJE |
150 | ||||||
Estimated Study Completion Date ICMJE | March 31, 2022 | ||||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Brazil, France, Israel, Italy, Russian Federation, Spain, Switzerland, Turkey | ||||||
Removed Location Countries | United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04023526 | ||||||
Other Study ID Numbers ICMJE | CR108609 2019-000473-23 ( EudraCT Number ) 74494550AML2001 ( Other Identifier: Janssen Research & Development, LLC ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Janssen Research & Development, LLC | ||||||
Study Sponsor ICMJE | Janssen Research & Development, LLC | ||||||
Collaborators ICMJE | argenx | ||||||
Investigators ICMJE |
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PRS Account | Janssen Research & Development, LLC | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |