AzTrials
AzTrials

AMLPhase 2AVSNCT05736978

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

A Phase 2 study testing Azacitidine, Venetoclax and Selinexor in people with AML and MRD, run by Shanghai Tong Ren Hospital at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 based on MRD results on day 14 of the first cycle. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML, MRD
What is being tested?
Azacitidine, Venetoclax and Selinexor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
4 sitesChina
Study dates
31 Mar 2023to 15 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 .
  • 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

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ligen Liu, MD contact

18017337037

liuligen@shsmu.edu.cn

China4 sites, 4 recruiting

  • Beizhan Hospital

    Shanghai

    Jie Hao

    Not yet recruiting

  • Pla Navy Feature Medical Center

    Shanghai

    Rong Li

    Not yet recruiting

  • Shanghai Ruijin Hospital

    Shanghai

    Junmin Li

    Not yet recruiting

  • Shanghai Tong Ren hospital

    Shanghai

    Ligen Liu

    Recruiting

Other trials in China

About this study

Official title: Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, 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 based on MRD results on day 14 of the first cycle.

Read the detailed description

Azacitidine and Venetoclax will be given at the approved dose regimen for 75mg/m2, d1-7(azacitidine) and 100mg on day 1 and 200mg on day 2, 400mg on day 3-28 (venetoclax), 28 days per cycle. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. 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, MRD
Being tested
Azacitidine, Venetoclax, Selinexor
Keywords
untreated AML, MRD results, selinexor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    75mg/m2 d1-7

  • VenetoclaxDrug

    Also called ABT-199

    d1 100mg, d2 200mg, d3-28 400mg

  • SelinexorDrug

    Also called XPO1 inhibitor

    if MRD positive in C1D14, selinexor 60mg D15, D22

Study groups in NCT05736978
Study groupRoleWhat they receive
Treatment regimen based on C1D14 MRDExperimentalUntreated acute myeloid leukemia who are ineligible for intensive chemotherapy will be given azacitidine 75mg/m2, d1-7 and venetoclax 100mg on day 1 and 200mg on day 2, 400mg on day 3-28. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. 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.
Receives: Drug: Azacitidine; Drug: Venetoclax; Drug: Selinexor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Composite Complete Remission

    Measured: From the study start up to death (up to approximately 2 years; )

Secondary outcomes (4)

  1. overall survival (OS)

    Measured: From the study start up to death (up to approximately 4 years; )

  2. Overall response rate(ORR)

    Measured: From the study start up to death (up to approximately 4 years; )

  3. percentage of patients who achieved MRD negativity

    Measured: From the study start up to death (up to approximately 4 years; )

  4. 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.

  1. First posted21 Feb 2023
  2. Study start31 Mar 2023 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05736978
Sponsor's protocol ID
AVS
Acronym
AVS
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine, Venetoclax and Selinexor in people with AML and MRD, run by Shanghai Tong Ren Hospital at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ligen Liu, MD (18017337037, liuligen@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Composite Complete Remission (time frame: From the study start up to death (up to approximately 2 years; )). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05736978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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