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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002808-41 | EudraCT Number | ||
| ELEV20235 | Other Identifier | OncoVerity, Inc. | |
| 74494550AML1003 | Other Identifier | Janssen Research & Development, LLC |
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| Name | Class |
|---|---|
| argenx | INDUSTRY |
| Janssen Research & Development, LLC | INDUSTRY |
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The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort 2: Cusatuzumab + Venetoclax | Experimental | Participants enrolled in this cohort will receive venetoclax ramp-up to 400 mg orally (as background therapy) starting on Cycle 1 Day 1 and followed by 400 mg daily dosing starting on Cycle 1 Day 4 plus cusatuzumab IV on Day 3 and Day 17 of each 28-day cycle. Cohort 2 will not be enrolled in the US. |
|
| Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA) | Experimental | Participants enrolled at US sites will receive cusatuzumab 10 mg/kg and potentially escalate to 20 mg/kg IV in combination with azacitidine 75 mg/m^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). Participants enrolled from ex-US sites will receive cusatuzumab 20 mg/kg and potentially de-escalate to 10 mg/kg IV in combination with azacitidine 75 mg/m^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cusatuzumab | Drug | Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety | Frequency and severity of AEs, laboratory abnormalities, and physical exam findings will be reported. | Up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Cusatuzumab | Serum concentration of cusatuzumab will be assessed. | Up to 23 months |
| Number of Participants with Anti-cusatuzumab Antibodies | Number of participants with anti-drug antibodies to cusatuzumab will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton Smith, MD | OncoVerity, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Norton Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37914483 | Derived | Pabst T, Papayannidis C, Demirkan F, Doronin V, Fogliatto LM, Guttke C, Gyan E, Hamad N, Herrera P, Hultberg A, Jacobs J, Johnson AJ, Langlois A, Ma X, Martinelli G, Arnan M, Muller R, Nottage K, Ofran Y, Ozcan M, Samoilova O, Tolbert JA, Trudel GC, Xiu L, Vey N, Wei AH. Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study. Lancet Haematol. 2023 Nov;10(11):e902-e912. doi: 10.1016/S2352-3026(23)00207-7. | |
| 37093350 |
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| Azacitidine | Drug | Azacitidine will be administered 75 mg/m^2 subcutaneously or intravenously. |
|
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| Venetoclax | Drug | Venetoclax will be administered orally and the dose will ramp-up to 400 mg. |
|
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| Up to 23 months |
| Percentage of Participants with Complete Response (CR) | Percentage of participants with complete response based on European Leukemia Network (ELN) 2017 response criteria assessment will be reported. | Up to 42 months |
| Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh) | Percentage of participants with CRh will be reported based on ELN 2017 response criteria assessment. | Up to 42 months |
| Percentage of Participants with CR with Incomplete Recovery (CRi) | Percentage of participants with CRi will be reported based on ELN 2017 response criteria assessment. | Up to 42 months |
| Percentage of Participants with CR plus CRh | Percentage of participants with CR plus CRh will be reported based on ELN 2017 response criteria assessment. | Up to 42 months |
| Overall Response Rate (ORR) | ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria assessment. | Up to 42 months |
| Percentage of Participants with CR without MRD | Percentage of participants with CR without minimal residual disease (MRD) will be reported and is defined as less than (<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3). | Up to 42 months |
| Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) | Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as < 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3). | Up to 42 months |
| Cohort 2 and 3: Time to Response | Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi. | Up to 42 months |
| Cohort 2 and 3: Duration of Response | Duration of response is defined as time from achieving the first response of CR, CRh, or CRi to hematologic relapse or death of any cause. | Up to 42 months |
| Cohort 2 and 3: Red Blood Cell (RBC) or Platelet Transfusion Independence | Transfusion independence (RBC or platelets) is defined as a period of greater than or equal to (>=) 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days. | Up to 42 months |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15232 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| Wisconsin Medical Center | Milwaukee | Wisconsin | 53226 | United States |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| University of Toronto | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Universitaetsklinik Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| Klinikum der Universitaet Muenchen | München | 81377 | Germany |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | 93-513 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-776 | Poland |
| INSELSPITAL, Universitätsspital Bern | Bern | 3010 | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | 9007 | Switzerland |
| Derived |
| Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3. |
| 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 |
| C579720 | venetoclax |
| 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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