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| ID | Type | Description | Link |
|---|---|---|---|
| 74494550AML1002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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| Name | Class |
|---|---|
| argenx | INDUSTRY |
| Janssen Pharmaceutical K.K. | INDUSTRY |
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The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are not candidates for intensive treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Dose Finding): Cusatuzumab + Azacitidine | Experimental | Participants with acute myeloid leukemia (AML) will receive cusatuzumab intravenously (IV) in combination with azacitidine subcutaneously (SC) or IV. The dose levels will be escalated based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
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| Part 2 (Dose Expansion): Cusatuzumab + Azacitidine | Experimental | Participants with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) will receive cusatuzumab intravenously (IV) at the recommended Phase 2 dose (RP2D) determined in Part 1 in combination with azacitidine subcutaneously (SC) or IV. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cusatuzumab | Drug | Cusatuzumab at a dose 20 milligram per kilogram (mg/kg) once every 2 weeks will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs and SAEs will be reported. | Up to 3 years |
| Part 1 and Part 2: Number of Participants with Dose-Limiting Toxicity (DLTs) | Number of participants with DLTs will be reported. | Up to 42 days |
| Part 1 and Part 2: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | Severity of DLT as assessed by NCI-CTCAE in participants will be reported. | Up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Percentage of Participants with Complete Response (CR) | Percentage of participants with complete response based on response criteria per investigator assessment in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) will be reported. | Up to 9 months |
| Part 1: Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan | |||
| Gunmaken Saiseikai Maebashi Hospital |
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| Azacitidine | Drug | Azacitidine at a dose 75 milligram per square meters (mg/m^2) will be administered subcutaneously or intravenously. |
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ORR is defined as percentage of participants with CR, CRh and CRi based on response criteria per investigator assessment in participants with AML. |
| Up to 6 months |
| Part 2: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with CR, partial response (PR) and marrow CR based on response criteria per investigator assessment in participants with MDS. | Up to 9 months |
| Part 2: Percentage of Participants with Hematologic Improvement (HI) | Percentage of participants with hematologic improvement will be reported according to response criteria per investigator assessment in participants with MDS. | Up to 9 months |
| Part 1 and Part 2: Time to Response | Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS.. | Up to 3 years |
| Part 1 and Part 2: Duration of Response | Duration of response is defined as time from achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS to hematologic relapse or death of any cause. | Up to 3 years |
| Part 1 and Part 2: Red Blood Cell (RBC) or Platelets Transfusion Independence | Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days. | Up to 3 years |
| Part 1 and Part 2: Overall Survival (OS) | OS is defined as the time from initial study intervention administration to death from any cause. | Up to 3 years |
| Part 1 and Part 2: Maximum Serum Concentration (Cmax) of Cusatuzumab | Cmax is the maximum observed serum concentration. | Up to 3 years |
| Part 1 and Part 2: Serum Trough Concentration (Ctrough) of Cusatuzumab | Ctrough is the serum concentration immediately prior to the next drug administration. | Up to 3 years |
| Maebashi |
| 371-0821 |
| Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| NTT Medical Center Tokyo | Tokyo | 141-8625 | Japan |
| University of Fukui Hospital | Yoshida | 910-1193 | Japan |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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