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Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax works to treat AML in adult participants who are ineligible for intensive induction chemotherapy in Canada.
Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive induction chemotherapy will be enrolled. Around 200 participants will be enrolled in the study in approximately 15-20 sites in Canada.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Participants | Participants treated with Venetoclax in accordance with approved local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS as defined by number of days from start of treatment to the completion of treatment or death from any cause. | Up to 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Complete Remission Rate | Composite Complete Remission Rate is defined as complete remission (CR) plus complete remission with incomplete hematologic recovery (CRi) as described by the modified International Working Group (IWG) criteria. | Up to 36 Months |
| Event-Free Survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
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Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Canada.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre /ID# 248113 | Calgary | Alberta | T2N 4N2 | Canada | ||
| University of Alberta Hospital /ID# 251531 |
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| Label | URL |
|---|---|
| Related Info. | View source |
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EFS as defined by number of days from start of treatment to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause. |
| Up to 36 Months |
| Percentage of Participants with Presence Transfusion Independence | Transfusion Independence is defined as at least 8 and/or 16 consecutive weeks without an Red Blood Cell (RBC) or platelet transfusion during the treatment period. | Up to 36 Months |
| Number of Participants with Transfusions | Number of Participants with transfusions (red blood cells and platelets). | Up to 36 Months |
| Number of Participants with Change in Venetoclax Dose | Number of participants with change in venetoclax dose. | Up to 36 Months |
| Number of Participants with Change in Other Medications | Number of participants with change in other medications. | Up to 36 Months |
| Venetoclax Administration Setting | Venetoclax administration setting (in-patient vs. out-patient vs. at home). | Up to 36 Months |
| Number of Hospital Admission | Number of hospital admission. | Up to 36 Months |
| Number of Participants with Change in use of Antiinfectives | Number of participants with change in use of antiinfectives. | Up to 36 Months |
| Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk | Number of participants with change in TLS risk. | Up to 36 Months |
| Occurrence of any Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment as graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). | Up to 36 Months |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| BC Cancer - Surrey /ID# 257515 | Surrey | British Columbia | V3V 1Z2 | Canada |
| Vancouver General Hospital /ID# 245438 | Vancouver | British Columbia | V5Z 1M9 | Canada |
| BC Cancer - Victoria /ID# 257339 | Victoria | British Columbia | V8R 6V5 | Canada |
| CancerCare Manitoba /ID# 246414 | Winnipeg | Manitoba | R3E 0V9 | Canada |
| The Moncton Hospital /ID# 247277 | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Eastern Regional Health Authority /ID# 250241 | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 246514 | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Juravinski Cancer Centre /ID# 247183 | Hamilton | Ontario | L8V 1C3 | Canada |
| Kingston Health Sciences Centre /ID# 253439 | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Center- University Hospital /ID# 248027 | London | Ontario | N6A 5W9 | Canada |
| Lakeridge Health - Oshawa /ID# 246412 | Oshawa | Ontario | L1G 2B9 | Canada |
| Thunder Bay Regional Research Institute /ID# 249163 | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Sunnybrook Health Sciences Centre /ID# 251966 | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network_Princess Margaret Cancer Centre /ID# 249607 | Toronto | Ontario | M5G 2M9 | Canada |
| Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 249704 | Montreal | Quebec | H4A 3J1 | Canada |
| CIUSSS de l'Estrie - CHUS /ID# 248915 | Sherbrooke | Quebec | J1G 2E8 | Canada |
| Allan Blair Cancer Centre /ID# 247663 | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre /ID# 247181 | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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