AMLNCT06265545
Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
A study testing Ivosidenib, Venetoclax and Gilteritinib in people with AML and Refractory, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AML, Refractory, Relapsed
- What is being tested?
- Ivosidenib, Venetoclax and Gilteritinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2024to 30 Jun 2028
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).
- 2. Meet criteria for refractory/recurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.
- 3. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Who cannot join
- Concurrent malignant tumors of other organs (patients requiring treatment).
- Participants considered unsuitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Blood Hospital
Tianjin, 300020
hui wei, MD, 86-13132507161, weihui@ihcams.ac.cn
About this study
To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.
- Conditions
- AML, Refractory, Relapsed
- Being tested
- Ivosidenib, Venetoclax, Gilteritinib, Homoharringtonine, Cytarabine
- Keywords
- AML, Refractory, Relapsed
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvosidenibDrug
in arm 1
VenetoclaxDrug
in arms 2-5
GilteritinibDrug
in arm 2
HomoharringtonineDrug
in arms 4 and 7
CytarabineDrug
in arms 3 and 7
Daunorubicin/ Idarubicin /MitoxantroneDrug
in arms 3 and 7
AzacitidineDrug
in arms 1，2 , 5 and 8
LisaftoclaxDrug
in arms 7 and 8
PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and othersDrug
in arm 6
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | With IDH1 gene mutation(up to 2 cycles available):IVA :
Ivosidenib 500mg d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax100mg d1, 200mg d2, 400mg d3, 800mg d4-14, d14-28(If the proportion of bone marrow blasts on day 14 is greater than 5% ) Receives: Drug: Ivosidenib; Drug: Venetoclax; Drug: Azacitidine |
| Arm 2 | Experimental | FLT3/ITD or FLT3/TKD gene mutation (up to 2 cycles available)
GVA:
Gilteritinib 80mg, d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax 100mg d1, 200mg d2, 400mg d3-14, 400mg d14-28 (if the proportion of bone marrow blasts on day 14 are greater than 5%) Receives: Drug: Venetoclax; Drug: Gilteritinib; Drug: Azacitidine |
| Arm 3 | Experimental | For R/R AML patients without IDH1 or FLT3 mutations who have not been exposed to Venecra in the last 3 months, the investigators will determine whether they are fit patients based on physical status and comorbidivities, and if they are, they can be randomly assigned to Arm3 or Arm4 DAV/IAV/MAV Cytarabine 100mg/m2/d, d1-5 Daunorubicin 60mg/m2/d, d1-2, or Idarubicin 12mg/m2/d, d1-2, or mitoxantrone 8mg/m2/d d1-2 Venetoclax 100mg d3, 200mg d4, 400mg d5-11; Receives: Drug: Venetoclax; Drug: Cytarabine; Drug: Daunorubicin/ Idarubicin /Mitoxantrone |
| Arm 4 | Experimental | HAV :
Cytarabine 100mg/m2/d, d1-5; Homoharringtonine 2mg/m2 d1-5; Venetoclax 100mg d3, 200mg d4, 400mg d5-11 Receives: Drug: Venetoclax; Drug: Homoharringtonine; Drug: Cytarabine |
| Arm 5 | Experimental | A patient with R/R AML without IDH1 or FLT3 mutation who has not been exposed to Venetoclax in the last 3 months but who is judged by the investigators to be unfit based on physical fitness and comorbidivities is unfit to enter Arm5.
Arm5: (up to 4 cycles available)
VA :
Azacytidine 75mg/m2/d d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-21 400mg d22-28 (if the proportion of bone marrow blasts on day 21 are greater than 5%) Receives: Drug: Venetoclax; Drug: Azacitidine |
| Arm 6 | Experimental | Patients with R/R AML without IDH1 or FLT3 mutations who have been exposed to Vinecra within the last 3 months may be enrolled in the exploratory protocol group based on a comprehensive assessment of local drug availability and patient status:
Arm6:
The Investigator's choice (IC) option involves a range of drugs such as clatabine, PI3K inhibitors, histone deacetylase inhibitors, celinisol, and novel liposomes. Receives: Drug: PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and others |
| Arm 7 | Experimental | DAV/IAV/MAV/HAV Regimen Cytarabine 100 mg/m²/day, days 1-5 Daunorubicin 60 mg/m²/day, days 1-2, or Idarubicin 12 mg/m²/day, days 1-2, or Mitoxantrone 8 mg/m²/day, days 1-2 / Homoharringtonine 2 mg/m²/day, days 1-5 Lisatoclax 200 mg on day 3, 400 mg on day 4, 600 mg on days 5-11 Receives: Drug: Homoharringtonine; Drug: Cytarabine; Drug: Daunorubicin/ Idarubicin /Mitoxantrone; Drug: Lisaftoclax |
| Arm 8 | Experimental | Azacitidine 75 mg/m²/day, days 1-7 Lisatoclax 200 mg on day 1, 400 mg on day 2, 600 mg on days 3-21, and 600 mg on days 22-28 (if bone marrow blast percentage on day 21 is greater than 5%) Receives: Drug: Azacitidine; Drug: Lisaftoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complex response (CRc) rate (including CR and CRi)
Proportion of patients with combined responses (complete and partial responses)
Measured: up to 4 years
Secondary outcomes (5)
mortality associated with salvage treatment (30 days, 60 days)
Mortality of patients treated within 30 and 60 days
Measured: Treatment within 30 days and 60 days
MRD-negative complete response rate
Proportion of patients with complete response and MRD negative
Measured: the whole period of the trial, up to 730 days
Overall survival
Used to evaluate all patients entering clinical trials
Measured: the whole period of the trial, up to 730 days
Event-free survival
It is only used to evaluate patients who have achieved CR
Measured: the whole period of the trial, up to 730 days
Relapse-free survival
It is only used to evaluate patients who have achieved CR
Measured: the whole period of the trial, up to 730 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start22 Feb 2024
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265545
- Sponsor's protocol ID
- IIT2024001
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06265545
- Acronym / sponsor ID
- IIT2024001
- Conditions
- AML, Refractory, Relapsed
- Keywords
- AML, Refractory, Relapsed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ivosidenib, Drug: Venetoclax, Drug: AzacitidineWith IDH1 gene mutation(up to 2 cycles available):IVA : Ivosidenib 500mg d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax100mg d1, 200mg d2, 400mg d3, 800mg d4-14, d14-28(If the proportion of bone marrow blasts on day 14 is greater than 5% ) |
| Arm 2 | Experimental | Drug: Venetoclax, Drug: Gilteritinib, Drug: AzacitidineFLT3/ITD or FLT3/TKD gene mutation (up to 2 cycles available) GVA: Gilteritinib 80mg, d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax 100mg d1, 200mg d2, 400mg d3-14, 400mg d14-28 (if the proportion of bone marrow blasts on day 14 are greater than 5%) |
| Arm 3 | Experimental | Drug: Venetoclax, Drug: Cytarabine, Drug: Daunorubicin/ Idarubicin /MitoxantroneFor R/R AML patients without IDH1 or FLT3 mutations who have not been exposed to Venecra in the last 3 months, the investigators will determine whether they are fit patients based on physical status and comorbidivities, and if they are, they can be randomly assigned to Arm3 or Arm4 DAV/IAV/MAV Cytarabine 100mg/m2/d, d1-5 Daunorubicin 60mg/m2/d, d1-2, or Idarubicin 12mg/m2/d, d1-2, or mitoxantrone 8mg/m2/d d1-2 Venetoclax 100mg d3, 200mg d4, 400mg d5-11; |
| Arm 4 | Experimental | Drug: Venetoclax, Drug: Homoharringtonine, Drug: CytarabineHAV : Cytarabine 100mg/m2/d, d1-5; Homoharringtonine 2mg/m2 d1-5; Venetoclax 100mg d3, 200mg d4, 400mg d5-11 |
| Arm 5 | Experimental | Drug: Venetoclax, Drug: AzacitidineA patient with R/R AML without IDH1 or FLT3 mutation who has not been exposed to Venetoclax in the last 3 months but who is judged by the investigators to be unfit based on physical fitness and comorbidivities is unfit to enter Arm5. Arm5: (up to 4 cycles available) VA : Azacytidine 75mg/m2/d d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-21 400mg d22-28 (if the proportion of bone marrow blasts on day 21 are greater than 5%) |
| Arm 6 | Experimental | Drug: PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and othersPatients with R/R AML without IDH1 or FLT3 mutations who have been exposed to Vinecra within the last 3 months may be enrolled in the exploratory protocol group based on a comprehensive assessment of local drug availability and patient status: Arm6: The Investigator's choice (IC) option involves a range of drugs such as clatabine, PI3K inhibitors, histone deacetylase inhibitors, celinisol, and novel liposomes. |
| Arm 7 | Experimental | Drug: Homoharringtonine, Drug: Cytarabine, Drug: Daunorubicin/ Idarubicin /Mitoxantrone, Drug: LisaftoclaxDAV/IAV/MAV/HAV Regimen Cytarabine 100 mg/m²/day, days 1-5 Daunorubicin 60 mg/m²/day, days 1-2, or Idarubicin 12 mg/m²/day, days 1-2, or Mitoxantrone 8 mg/m²/day, days 1-2 / Homoharringtonine 2 mg/m²/day, days 1-5 Lisatoclax 200 mg on day 3, 400 mg on day 4, 600 mg on days 5-11 |
| Arm 8 | Experimental | Drug: Azacitidine, Drug: LisaftoclaxAzacitidine 75 mg/m²/day, days 1-7 Lisatoclax 200 mg on day 1, 400 mg on day 2, 600 mg on days 3-21, and 600 mg on days 22-28 (if bone marrow blast percentage on day 21 is greater than 5%) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).
- 2. Meet criteria for refractory/recurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.
- 3. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Key exclusion criteria (2 listed)
- Concurrent malignant tumors of other organs (patients requiring treatment).
- Participants considered unsuitable for inclusion by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivosidenibin arm 1 | Drug | Arm 1 |
| Venetoclaxin arms 2-5 | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| Gilteritinibin arm 2 | Drug | Arm 2 |
| Homoharringtoninein arms 4 and 7 | Drug | Arm 4, Arm 7 |
| Cytarabinein arms 3 and 7 | Drug | Arm 3, Arm 4, Arm 7 |
| Daunorubicin/ Idarubicin /Mitoxantronein arms 3 and 7 | Drug | Arm 3, Arm 7 |
| Azacitidinein arms 1，2 , 5 and 8 | Drug | Arm 1, Arm 2, Arm 5, Arm 8 |
| Lisaftoclaxin arms 7 and 8 | Drug | Arm 7, Arm 8 |
| PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and othersin arm 6 | Drug | Arm 6 |
Primary outcome
Complex response (CRc) rate (including CR and CRi)
Time frame: up to 4 years
Proportion of patients with combined responses (complete and partial responses)
5 secondary outcomes
mortality associated with salvage treatment (30 days, 60 days)
Time frame: Treatment within 30 days and 60 days
MRD-negative complete response rate
Time frame: the whole period of the trial, up to 730 days
Overall survival
Time frame: the whole period of the trial, up to 730 days
Event-free survival
Time frame: the whole period of the trial, up to 730 days
Relapse-free survival
Time frame: the whole period of the trial, up to 730 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivosidenib, Venetoclax and Gilteritinib in people with AML and Refractory, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site 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 3 inclusion and 2 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complex response (CRc) rate (including CR and CRi) (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.