Acute Myeloid Leukemia (AML)Phase 2NCT06652685
Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study testing D5-PBCR(-) IA arm and D5-PBCR(+) IA+Venetoclax arm in people with Acute Myeloid Leukemia (AML), run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- D5-PBCR(-) IA arm and D5-PBCR(+) IA+Venetoclax arm
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Jun 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bone marrow morphology and immunology confirmed newly diagnosed AML patients (according to 2022 ICC criteria)
- Exclude patients with APL and CBF-AML (according to fusion genes and chromosomes)
- Performance status score 0-2 (ECOG score)
- Age 18~59 years old
- Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, creatinine ≤ 150 μmol/L
- Normal cardiac function (EF ≥50%)
- Obtained informed consent signed by the patient or family member
Who cannot join
- FAB classification is M3, or confirmed APL at the molecular level
- CBF-AML
- Patients who have already been treated
- Comfirmed central nervous system leukemia
- Allergy to any of the drugs involved in the protocol
- Medical condition or organ system dysfunction that precludes the inability to swallow capsules or tablets, or has a disease that significantly affects gastrointestinal function and/or inhibits small bowel absorption (including malabsorption syndrome, small bowel resection, or poorly controlled inflammatory bowel disease)
Show all 17Show fewer
- Cardiac function and disease consistent with one of the following: a) long QTc syndrome or QTc interval >480 ms; b) second- or third-degree atrioventricular block; Severe, uncontrolled cardiac arrhythmias requiring medication; c) United States New York College of Cardiology Grade ≥ III; d) Ventricular ejection fraction (LVEF) less than 50%; e) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction abnormalities within 6 months prior to recruitment
- Previous or present concomitant malignancies (except for basal cell carcinoma of the skin that have been effectively controlled as non-melanoma, carcinoma in situ of the breast/cervix, and other malignancies that have not been effectively controlled for more than 6 months, and patients who have been receiving long-term non-chemotherapy treatments such as hormonal therapy)
- Significant abnormalities in liver and kidney function (serum bilirubin, aspartate aminotransferase, alanine aminotransferase or serum creatinine more than 2 times the upper limit of normal reference values; Excluded from AML-related as judged by the investigator)
- Patients who have previously used other drugs for the treatment of AML (except hydroxyurea and cytarabine for cell count control), including but not limited to BCL2, FLT3, IDH1, IDH2 inhibitors, or other drugs in clinical trials
- Coagulopathy not associated with AML
- HIV infection, syphilis infection, HCV infection, active HBV infection (HBsAg positive, or HBsAg negative but HBcAb positive with HBV DNA > 1.0 ×ULN)
- Other uncontrolled active infection (as judged by the investigator)
- Pregnant or lactating women
- Inability to understand or follow the study protocol
- Participation in other relevant clinical studies within 30 days (except diagnostic clinical studies)
- Patients who in the opinion of the investigator, are not suitable to participate in this study
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
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Yang Shen, +86-021-64370045, sy_clinicaltrial@163.com
About this study
Official title: Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Young Treatment-naive Acute Myeloid Leukemia: a Multicenter, Phase II Study
This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib.
Subjects will receive standard intensive chemotherapy during induction and consolidation. Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). Venetoclax will be added in D5-PBCR positive subjects. For subjects with FLT3 mutations, Gilteritinib will be combined.
Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations (ELN risk) and MRD status to receive specific consolidation therapy after the induction therapy.
Read the detailed description
Young patients with naïve AML (excluding APL and CBF-AML) were included in this study. 218 subjects who meet the eligibility criteria will receive the standard 3+7 intensive chemotherapy induction, containing cytarabine and idarubicin. On the basis of the IA induction regimen, the early chemotherapy response was evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). For D5-PBCR-positive patients, venetoclax will be added to conventional chemotherapy. For patients with FLT3 mutations, gilteritinib will be combined.
Subjects who achieve a composite complete remission (CRc) after induction therapy will receive further consolidation therapy, which regimen will be decided based on the ELN risk at diagnosis and MRD status detected by MFC and gene quantification after induction therapy.
The purpose of the study is to determine whether the addition of drug "X" to the standard induction regimen improves efficacy in the treatment of naïve AML.
Primary objective: To evaluate whether intensive IA combined with targeted drug (drug "X") regimens can improve the composite response rate (CRc) after 1 course of induction therapy in newly diagnosed young AML patients Secondary Objective: To evaluate whether intensive chemotherapy combined with drug "X" during induction and consolidation can improve overall response rates, overall survival, and event-free survival in newly diagnosed young AML patients Safety indicators: incidence of adverse reactions during treatment, recovery time of neutrophils and platelets
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- D5-PBCR(-) IA arm, D5-PBCR(+) IA+Venetoclax arm
- Keywords
- Acute myeloid leukemia, venetoclax, gilteritinib, D5-PBCR, Risk-stratified
- 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.
D5-PBCR(-) IA armDrug
Induction: IA Drug: idarubicin, intravenously, 10 mg/m^2 on D1-3 Drug: cytarabine, intravenously, 100 mg/m^2 on D1-7
Consolidation:
Subjects who achieve composite complete remission (CRc) proceed with consolidation therapy.
In consolidation therapy phase, subjects in the group with favorable/intermediate risk and MRD negetive, will receive cytarabine intravenously at 2g/m^2/q12h*6 doses. Subjects in the group with adverse risk or MRD positive will receive cytarabine intravenously at 2g/m^2/q12h*6 doses together with venetoclax 400mg on D4-10. Dose ramp-up of venetoclax is not required.
After two cycles of consolidation, a multi-disciplinary team will discuss whether the patient need allogeneic hematopoietic stem-cell transplant (allo-HSCT) according to ELN risk stratification and MRD status.
D5-PBCR(+) IA+Venetoclax armDrug
Induction: IA+Ven Drug: idarubicin, intravenously, 10 mg/m^2, on D1-3, Drug: cytarabine, intravenously, 100 mg/m^2 on D1-7 For D5-PBCR (+) patients, Venetoclax will be combined. Drug: Venetoclax. Orally once daily, on D6-14. A 3-day dose ramp-up is required for the first induction (100mg D6, 200mg D7, 400mg D8-14) If a second induction is needed, the dose of IA is the same as the first cycle, and dose ramp-up of venetoclax is not required.
Consolidation:
Subjects who achieve composite complete remission (CRc) proceed with consolidation therapy.
In consolidation therapy phase, subjects in the group will receive cytarabine intravenously at 2g/m^2/q12h*6 doses together with venetoclax 400mg on D4-10. Dose ramp-up of venetoclax is not required.
After two cycles of consolidation, a multi-disciplinary team will discuss whether the patient need allogeneic hematopoietic stem-cell transplant (allo-HSCT) according to ELN risk stratification and MRD status.
| Study group | Role | What they receive |
|---|---|---|
| D5-PBCR(-) | Experimental | On day five of IA induction, D5-PBCR will be tested according to protocol. For D5-PBCR (-) patients, no additional of venetoclax is needed. Receives: Drug: D5-PBCR(-) IA arm |
| D5-PBCR(+) | Experimental | On day five of induction, D5-PBCR will be tested according to protocol. D5-PBCR (+) patients, will receive induction therapy consisting of venentoclax combined with IA regimen. Receives: Drug: D5-PBCR(+) IA+Venetoclax arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complete remission rate
Complete remission/complete remission with partial hematological recovery/complete remission with incomplete hematological recovery
Measured: At the end of cycle one (up to 42 days from the start of cycle 1）
Secondary outcomes (5)
Total composite complete remission rate
Complete remission/complete remission with partial hematological recovery/complete remission with incomplete hematological recovery
Measured: At the end of induction cycle 2 (up to 42 days from the start of cycle 2)
OS
overall survival rate
Measured: 2-year
EFS
event free survival rate
Measured: 2-year
AE
Adverse Events (AEs), Serious Adverse Events (SAEs) Based on NCI-CTCAE 5.0 Assessment
Measured: Throughout the entire study period, an average of 1 year
Recovery time for neutrophils and platelets
The time from the first day of induction therapy to the recovery of neutrophils to a count greater than 0.5*10^9/L and platelets to greater than 20*10^9/L
Measured: During induction cycle one (up to 42 days from the start of cycle 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects receive IA regimen as the initial induction. On day five of induction, D5-PBCR will be tested according to protocol. Patients will be assigned to different arms according to the result of D5-PBCR. For FLT3 mutate patients, a combination of gilteritinib will be recommended in this study. Induction and consolidation phase: gilteritinib 80mg on D8-14.
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen yang, Ruijin Hospital
- Investigators
- Yang Shen, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652685
- Sponsor's protocol ID
- IA+X 2024
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Li X, Weng X, Shen Y, Chen Y, Zheng Y, Zhao H, You J, Mao Y, Wang L, Wu M, Sheng Y, Wu J, Hu J, Chen Q, Li J. Optimization of idarubicin and cytarabine induction regimen with homoharringtonine for newly diagnosed acute myeloid leukemia patients based on the peripheral blast clearance rate: A single-arm, phase 2 trial (RJ-AML 2014). Am J Hematol. 2022 Jan 1;97(1):43-51. doi: 10.1002/ajh.26386. Epub 2021 Nov 1.
PubMed 34687467Yu C, Kong QL, Zhang YX, Weng XQ, Wu J, Sheng Y, Jiang CL, Zhu YM, Cao Q, Xiong SM, Li JM, Xi XD, Chen SJ, Chen B. Clinical significance of day 5 peripheral blast clearance rate in the evaluation of early treatment response and prognosis of patients with acute myeloid leukemia. J Hematol Oncol. 2015 May 10;8:48. doi: 10.1186/s13045-015-0145-1.
PubMed 25957890
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Young Treatment-naive Acute Myeloid Leukemia: a Multicenter, Phase II Study
- ClinicalTrials.gov ID
- NCT06652685
- Acronym / sponsor ID
- IA+X 2024
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute myeloid leukemia, venetoclax, gilteritinib, D5-PBCR, Risk-stratified
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Oct 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.
This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib.
Subjects will receive standard intensive chemotherapy during induction and consolidation. Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). Venetoclax will be added in D5-PBCR positive subjects. For subjects with FLT3 mutations, Gilteritinib will be combined.
Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations (ELN risk) and MRD status to receive specific consolidation therapy after the induction therapy.
Detailed description
Young patients with naïve AML (excluding APL and CBF-AML) were included in this study. 218 subjects who meet the eligibility criteria will receive the standard 3+7 intensive chemotherapy induction, containing cytarabine and idarubicin. On the basis of the IA induction regimen, the early chemotherapy response was evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). For D5-PBCR-positive patients, venetoclax will be added to conventional chemotherapy. For patients with FLT3 mutations, gilteritinib will be combined.
Subjects who achieve a composite complete remission (CRc) after induction therapy will receive further consolidation therapy, which regimen will be decided based on the ELN risk at diagnosis and MRD status detected by MFC and gene quantification after induction therapy.
The purpose of the study is to determine whether the addition of drug "X" to the standard induction regimen improves efficacy in the treatment of naïve AML.
Primary objective: To evaluate whether intensive IA combined with targeted drug (drug "X") regimens can improve the composite response rate (CRc) after 1 course of induction therapy in newly diagnosed young AML patients Secondary Objective: To evaluate whether intensive chemotherapy combined with drug "X" during induction and consolidation can improve overall response rates, overall survival, and event-free survival in newly diagnosed young AML patients Safety indicators: incidence of adverse reactions during treatment, recovery time of neutrophils and platelets
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects receive IA regimen as the initial induction. On day five of induction, D5-PBCR will be tested according to protocol. Patients will be assigned to different arms according to the result of D5-PBCR. For FLT3 mutate patients, a combination of gilteritinib will be recommended in this study. Induction and consolidation phase: gilteritinib 80mg on D8-14.
| Arm | Type | Receives |
|---|---|---|
| D5-PBCR(-) | Experimental | Drug: D5-PBCR(-) IA armOn day five of IA induction, D5-PBCR will be tested according to protocol. For D5-PBCR (-) patients, no additional of venetoclax is needed. |
| D5-PBCR(+) | Experimental | Drug: D5-PBCR(+) IA+Venetoclax armOn day five of induction, D5-PBCR will be tested according to protocol. D5-PBCR (+) patients, will receive induction therapy consisting of venentoclax combined with IA regimen. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Bone marrow morphology and immunology confirmed newly diagnosed AML patients (according to 2022 ICC criteria)
- Exclude patients with APL and CBF-AML (according to fusion genes and chromosomes)
- Performance status score 0-2 (ECOG score)
- Age 18~59 years old
- Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, creatinine ≤ 150 μmol/L
Key exclusion criteria (17 listed)
- FAB classification is M3, or confirmed APL at the molecular level
- CBF-AML
- Patients who have already been treated
- Comfirmed central nervous system leukemia
- Allergy to any of the drugs involved in the protocol
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 |
|---|---|---|
| D5-PBCR(-) IA armInduction: IA Drug: idarubicin, intravenously, 10 mg/m^2 on D1-3 Drug: cytarabine, intravenously, 100 mg/m^2 on D1-7 Consolidation: Subjects who achieve composite complete remission (CRc) proceed with consolidation therapy. In consolidation therapy phase, subjects in the group with favorable/intermediate risk and MRD negetive, will receive cytarabine intravenously at 2g/m^2/q12h*6 doses. Subjects in the group with adverse risk or MRD positive will receive cytarabine intravenously at 2g/m^2/q12h*6 doses together with venetoclax 400mg on D4-10. Dose ramp-up of venetoclax is not required. After two cycles of consolidation, a multi-disciplinary team will discuss whether the patient need allogeneic hematopoietic stem-cell transplant (allo-HSCT) according to ELN risk stratification and MRD status. | Drug | D5-PBCR(-) |
| D5-PBCR(+) IA+Venetoclax armInduction: IA+Ven Drug: idarubicin, intravenously, 10 mg/m^2, on D1-3, Drug: cytarabine, intravenously, 100 mg/m^2 on D1-7 For D5-PBCR (+) patients, Venetoclax will be combined. Drug: Venetoclax. Orally once daily, on D6-14. A 3-day dose ramp-up is required for the first induction (100mg D6, 200mg D7, 400mg D8-14) If a second induction is needed, the dose of IA is the same as the first cycle, and dose ramp-up of venetoclax is not required. Consolidation: Subjects who achieve composite complete remission (CRc) proceed with consolidation therapy. In consolidation therapy phase, subjects in the group will receive cytarabine intravenously at 2g/m^2/q12h*6 doses together with venetoclax 400mg on D4-10. Dose ramp-up of venetoclax is not required. After two cycles of consolidation, a multi-disciplinary team will discuss whether the patient need allogeneic hematopoietic stem-cell transplant (allo-HSCT) according to ELN risk stratification and MRD status. | Drug | D5-PBCR(+) |
Primary outcome
Composite complete remission rate
Time frame: At the end of cycle one (up to 42 days from the start of cycle 1）
Complete remission/complete remission with partial hematological recovery/complete remission with incomplete hematological recovery
5 secondary outcomes
Total composite complete remission rate
Time frame: At the end of induction cycle 2 (up to 42 days from the start of cycle 2)
OS
Time frame: 2-year
EFS
Time frame: 2-year
AE
Time frame: Throughout the entire study period, an average of 1 year
Recovery time for neutrophils and platelets
Time frame: During induction cycle one (up to 42 days from the start of cycle 1)
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 22 Oct 2024.
- Background: PubMed 34687467Zhang Y, Li X, Weng X, Shen Y, Chen Y, Zheng Y, Zhao H, You J, Mao Y, Wang L, Wu M, Sheng Y, Wu J, Hu J, Chen Q, Li J. Optimization of idarubicin and cytarabine induction regimen with homoharringtonine for newly diagnosed acute myeloid leukemia patients based on the peripheral blast clearance rate: A single-arm, phase 2 trial (RJ-AML 2014). Am J Hematol. 2022 Jan 1;97(1):43-51. doi: 10.1002/ajh.26386. Epub 2021 Nov 1.
- Background: PubMed 25957890Yu C, Kong QL, Zhang YX, Weng XQ, Wu J, Sheng Y, Jiang CL, Zhu YM, Cao Q, Xiong SM, Li JM, Xi XD, Chen SJ, Chen B. Clinical significance of day 5 peripheral blast clearance rate in the evaluation of early treatment response and prognosis of patients with acute myeloid leukemia. J Hematol Oncol. 2015 May 10;8:48. doi: 10.1186/s13045-015-0145-1.
- Individual participant dataSharing planned: No
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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.
Yang Shen principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D5-PBCR(-) IA arm and D5-PBCR(+) IA+Venetoclax arm in people with Acute Myeloid Leukemia (AML), run by Ruijin Hospital 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 7 inclusion and 17 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: opening soon, as of the sponsor's last update on 22 Oct 2024. 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.
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 Yunxiang Zhang (+86-13564516001, zyx12103@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite complete remission rate (time frame: At the end of cycle one (up to 42 days from the start of cycle 1）). 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 NCT06652685, which also lists 2 linked publications.
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 22 Oct 2024.