Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004941-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-486 in combination with Venetoclax | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-486 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Up to 42 days after first dose | |
| Incidence of type of adverse events (AEs) | From informed consent form (ICF) signature to 28 days after last dose of study drug | |
| Incidence of frequency of AEs | From informed consent form (ICF) signature to 28 days after last dose of study drug | |
| Incidence of severity of AEs | From informed consent form (ICF) signature to 28 days after last dose of study drug | |
| Incidence of relationship of AEs to study treatment | From informed consent form (ICF) signature to 28 days after last dose of study drug | |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | From informed consent form (ICF) signature to 28 days after last dose of study drug | |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | From informed consent form (ICF) signature to 28 days after last dose of study drug | |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | From informed consent form (ICF) signature to 28 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh) | Up to approximately 12 months | |
| Overall Response Rate (ORR) | Up to approximately 12 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 104 | Stanford | California | 94305-5317 | United States | ||
| Local Institution - 110 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
See Plan Description
See Plan Description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Venetoclax | Drug | Specified dose on specified days |
|
|
| Minimal Residual Disease (MRD) Response Rate |
| Up to approximately 12 months |
| MRD Conversion Rate | Up to approximately 12 months |
| Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi) | Up to approximately 12 months |
| Denver |
| Colorado |
| 80218 |
| United States |
| Local Institution - 105 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 106 | New York | New York | 10029 | United States |
| Local Institution - 113 | New York | New York | 10065 | United States |
| Local Institution - 102 | Cleveland | Ohio | 44195 | United States |
| Local Institution - 111 | Oklahoma City | Oklahoma | 73104 | United States |
| Local Institution - 101 | Houston | Texas | 77003 | United States |
| Local Institution - 202 | North Melbourne | Victoria | 3002 | Australia |
| Local Institution - 201 | Melbourne | 3004 | Australia |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709231 | cc-486 |
| 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 |
Not provided
Not provided