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New treatment option for Acute Myeloid Leukemia
Official title A Study of BGB-11417 in Participants With Myeloid Malignancies
ClinicalTrials.gov ID: NCT04771130
What this study is testing
What is BGB-11417?
BGB-11417 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Sonrotoclax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- AML, nonacute promyelocytic leukemia
- MDS/MPN
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Adequate organ function defined as:
You likely can't join if
- A diagnosis of acute promyelocytic leukemia.
- History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was...
- Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1...
- Prior therapy with a B-cell lymphoma-2 inhibitor
- Known central nervous system involvement by leukemia. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full eligibility criteria
- Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- AML, nonacute promyelocytic leukemia
- MDS/MPN
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Adequate organ function defined as:
- Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
- Adequate liver function
- Life expectancy of \> 12 weeks.
- Ability to comply with the requirements of the study. Key
- A diagnosis of acute promyelocytic leukemia.
- History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence...
- Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Prior therapy with a B-cell lymphoma-2 inhibitor
- Known central nervous system involvement by leukemia. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
- Concord, New South Wales, Australia
- Kogarah, New South Wales, Australia
- Orange, New South Wales, Australia
- Southport, Queensland, Australia
- Clayton, Victoria, Australia
- Fitzroy, Victoria, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- Murdoch, Western Australia, Australia
- Nedlands, Western Australia, Australia
- Beijing, Beijing Municipality, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhengzhou, Henan, China
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, United States; Milwaukee, Wisconsin, United States; Concord, New South Wales, Australia and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.