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New treatment option for AML, Adult
Official title A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05736965
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for aml, adult.
Also referred to as xpo1 inhibitor.
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
- This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.
- 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
- Known and written informed consent voluntarily
- Age ≥ 18 years
- Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:
- ≥75 years or
- Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or...
You likely can't join if
- History of any malignancies prior to study entry with exception noted in the protocol.
- Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .
- Participant has known active central nervous system (CNS) involvement with AML.
- Must not have received prior anti-AML treatment except for hydroxyurea
See the full eligibility criteria
- Known and written informed consent voluntarily
- Age ≥ 18 years
- Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:
- ≥75 years or
- Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring...
- patients who are suitable for intensive chemotherapy but refuse it
- Liver function meets the following criteria: aspartate aminotransferase (AST) ≤ 3.0×ULN\ ; alanine aminotransferase (ALT) ≤ 3.0×ULN\ ; Bilirubin≤1.5×ULN\ ; For people \<75 years old, the bilirubin level can be ≤3.0×ULN;
- Unless due to leukemic organ involvement.
- Renal function meets the following criteria: creatinine clearance ≥ 30 mL/min (Cockroft-Gault formula)
- Life expectancy ≥ 4 weeks
- History of any malignancies prior to study entry with exception noted in the protocol.
- Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .
- Participant has known active central nervous system (CNS) involvement with AML.
- Must not have received prior anti-AML treatment except for hydroxyurea
The study team makes the final eligibility decision.
Where it's taking place
- Changzhou, China
- Chengdu, China
- Ch’ang-ch’un, China
- Ha’erbin, China
- Hefei, China
- Jiaxing, China
- Lanzhou, China
- Ningbo, China
- Shanghai, China
- Shenyang, China
- Shijia Zhuang, China
- Ürümqi, China
- Wuhu, China
- Xi'an, China
- Yangzhou, China
- Yixing, China
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 Changzhou, China; Chengdu, China; Ch’ang-ch’un, China; Ha’erbin, China; Hefei, China; Jiaxing, China and 10 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.