AML, AdultPhase 2SAVNCT05736965
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
A Phase 2 study testing Selinexor, Azacitidine and Venetoclax in people with AML, Adult, run by Shanghai Tong Ren Hospital at 19 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- Selinexor, Azacitidine and Venetoclax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 19 sitesChina
- Study dates
- 20 Feb 2023to 30 Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 treatment or Ejection Fraction <= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; Creatinine clearance >= 30 mL/min to < 45 ml/min; Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy .
- patients who are suitable for intensive chemotherapy but refuse it
Show all 11Show fewer
- Liver function meets the following criteria:
- aspartate aminotransferase (AST) ≤ 3.0×ULN; alanine aminotransferase (ALT) ≤ 3.0×ULN; Bilirubin≤1.5×ULN; For subjects <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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites, 19 recruiting
- Not yet recruiting
Jilin University China Japan Union Hospital
Ch’ang-ch’un
yuansong bai
- Not yet recruiting
Changzhou Municipal No.1 People's Hospital
Changzhou
weiying gu
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu
hui li
- Not yet recruiting
Harbin Institute of Hematology and Oncology
Ha’erbin
hong liang
- Not yet recruiting
Anhui Provincial Hospital
Hefei
xiaoyu zhu
- Not yet recruiting
the first hospital of Jiaxing affiliated hospital of Jiaxing University
Jiaxing
hui zeng
- Not yet recruiting
Gansu Provincial People's Hospital
Lanzhou
qike zhang
- Not yet recruiting
Lanzhou University NO.2 Hospital
Lanzhou
pengyun zeng
- Not yet recruiting
Ningbo Medical Center Lihuili Huspital
Ningbo
jing le
- Not yet recruiting
Shanghai Ruijin Hospital
Shanghai
Junmin Li
- Recruiting
Shanghai Tong Ren hospital
Shanghai
Ligen Liu, 18017337037, llg3532@shtrhospital.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang
xiaojing yan
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijia Zhuang
qingchi liu
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijia Zhuang
jinhai ren
- Not yet recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi
ming jiang
- Not yet recruiting
the Second Affiliated Hospital of Wannan Medical College
Wuhu
dongping huang
- Not yet recruiting
Xi'an International Medical Center
Xi'an
yingmin liang
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou
mei su
- Not yet recruiting
Yixing People's Hospital
Yixing
wenzhong wu
About this study
Official title: Clinical Efficacy and Safety of Selinexol Combined With Azacitidine and Venetoclax (SAV Regimen) in the Treatment of Acute Myeloid Leukemia (AML)-a Multi-center, Single-arm, Prospective Clinical Study
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.
Read the detailed description
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.
Selinexor will be given orally at 60mg, d3,10,17 Azacitidine will be given at 75mg/m2, d1-3, 8-9, 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2, 400mg on day 3-14
28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects.
- Conditions
- AML, Adult
- Being tested
- Selinexor, Azacitidine, Venetoclax
- Keywords
- selinexor, untreated AML, azacitidine, venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called xpo1 inhibitor
Selinexor 60mg, PO d3,10,17
AzacitidineDrug
Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
VenetoclaxDrug
Also called ABT199
Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
| Study group | Role | What they receive |
|---|---|---|
| SAV arm | Experimental | Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects. Receives: Drug: Selinexor; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Composite Complete Remission
composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.
Measured: From the study start up to death (up to approximately 2 years; )
Secondary outcomes (4)
overall survival (OS)
Measured: From the study start up to death (up to approximately 4 years; )
Overall response rate(ORR)
Measured: From the study start up to death (up to approximately 4 years; )
percentage of patients who achieved MRD negativity
Measured: From the study start up to death (up to approximately 4 years; )
Recurrence Free Survival(RFS)
Measured: From the study start up to death (up to approximately 4 years; )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start20 Feb 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Ligen, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736965
- Sponsor's protocol ID
- SAV
- Acronym
- SAV
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No