AML, ChildhoodPhase 2GMCAIINCT06221683
Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
A Phase 2 study testing Homoharringtonine, Cytarabine and Etoposide in people with AML, Childhood and Acute Myeloid Leukemia, run by Children's Hospital of Soochow University at 13 sites in China.
Trial summary
The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR/CRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- AML, Childhood, Acute Myeloid Leukemia
- What is being tested?
- Homoharringtonine, Cytarabine and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 13 sitesChina
- Study dates
- 1 Jan 2024to Dec 2029
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1、Newly diagnosed, untreated AML；
- 2、Under 18 years old;
- 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg/m2 (50 mg/m2, q12h × 5d)；
- 4、 Liver function：Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min；Cardiac NYHA grading<3；SaO2>92%;
- 5、No active infection (symptoms resolved for more than 3 days if infected)
- 6、ECOG<2;
- 7、Expected survival time greater than 12 weeks;
- 9、Obtain the consent of the child and/or guardian and sign the informed consent form.
Who cannot join
- 1、Acute megakaryocytic leukemia (AMKL)；
- 2、Acute promyelocytic leukemia (APL);
- 3、Treatment-related secondary AML and AML with definite MDS transformation；
- 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML);
- 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；
- 6、AML secondary to Down syndrome;
Show all 12Show fewer
- 7、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan;
- 8、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol;
- 9、Having any significant abnormal concurrent disease or mental illness that impacts the life safety and compliance of the patient and impacts informed consent, study participation, follow-up, or interpretation of results. In this case, all the participating units are required to report directly to the responsible person for this project to jointly decide whether they meet the exclusion criteria；
- 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy;
- 11、Relapsed AML at any time；
- 12、The attending physician considers that the patient is not suitable for entering the study protocol based on the patient's physical condition, economic status, and other factors.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Not yet recruiting
Beijing Institute of Genomics, Chinese Academy of Sciences
Beijing, 100000
Qianfei Wang, PhD, +86-15611132448, wangqf@big.ac.cn
- Not yet recruiting
Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Minghua Yang, MD, +86-13973135843, yamahua123@163.com
- Not yet recruiting
XiangYa Hospital Central South University
Changsha, Hunan, 410008
Liangchun Yang, MD, +86-13974927514, yangliangchung@163.com
- Not yet recruiting
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, 510000
Hua Jiang, MD, +86-13533330985, jiang_hua18@sina.cn
- Not yet recruiting
First Affiliated Hospital Of University of Science and Technology of China
Hefei, Anhui, 230000
Hongjun Liu, MD, +86-13515657759, 13515657759@126.com
- Not yet recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000
Ninglin Wang, MD, +86-13721113063, zwnltt@126.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Xiuli Ju, MD, +86-13869192944, shellysdcn@hotmail.com
- Not yet recruiting
Kaifeng Children's Hospital
Kaifeng, Henan, 475000
Jixia Luo, MD, +86-13592146539, luojixia@163.com
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000
Ning Liao, MD, +86-13978812808, ln12808@163.com
- Not yet recruiting
Children's Hospital Of Fudan University
Shanghai, Shanghai Municipality, 200000
Xiaowen Zhai, MD, +86-18017590808, zhaixiaowendy@163.com
- Recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215000
Shaoyan Hu, MD, PhD, +8613771835430, hsy139@126.com
Shaoyan Hu, MD,PhD
- Not yet recruiting
Xuzhou Children's Hospital
Xuzhou, Jiangsu, 221000
Qi An, MD, +86-13814422329, anqi1974@sina.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yufeng Liu, MD, +86-13673666608, lyf6012@126.com
About this study
Official title: A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)
The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR/CRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular/precision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.
Read the detailed description
Advances in risk stratification and therapy, have improved the event-free survival (EFS) and overall survival (OS) for pediatric acute myeloid leukemia (AML) with current treatment strategies. Investigators previously conducted a multicenter, randomized controlled trial (AML18) to compare the efficacy and safety of low-dose chemotherapy versus standard-dose chemotherapy. The results showed that low-dose chemotherapy was non-inferior to standard-dose chemotherapy in terms of efficacy and had fewer adverse events. However, different subtypes exhibited varying treatment responses to both chemotherapy regimens. The MRD (Measurable Residual Disease) after induction therapy in both groups had an impact on prognosis. According to the backbone of the 2018 protocol, investigators decide whether to use low-dose or standard-dose for the first induction according to the patient's fusion gene, and the second induction and subsequent treatment are adjusted according to the treatment response. Patients with the following 5 fusion genes RUNX1: RUNX1T1, CBFβ: MYH11, KMT2A: MLLT3 (AF9), KMT2A: MLLT10 (AF10), KMT2A: MLLT4 (AF6) fusion or KIT mutation will be assigned to the standard dose remission induction regimen (HHT + Ara-C + VP16), others will be assigned to the standard dose regimen (Mitoxantrone/Idarubicin + Ara-C + G-CSF). At the same time, investigators will add targeted drugs such as venetoclax, avaptitinib, and gilteritinib/sorafenib to the chemotherapy regimen and assess their safety and efficacy. Post-induction consolidation consisted of 3 to 4 cycles of standard-dose chemotherapy according to risk classification. Patients classified as high-risk are candidates for allogeneic bone marrow transplantation after 1 or 2 courses of consolidation.
- Conditions
- AML, Childhood, Acute Myeloid Leukemia
- Being tested
- Homoharringtonine, Cytarabine, Etoposide, Venetoclax, Mitoxantrone hydrochloride liposome
- Keywords
- AML, Childhood, Molecular subtyping, MRD
- 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.
HomoharringtonineDrug
Also called Homoharringtonine injection
3mg/m2/day for weighing >10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours
CytarabineDrug
Also called Cytosar
100mg/m2/q12h for weighing >10kg, 3.3mg/kg/q12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg/m2/q12h for weighing >10kg, 0.33mg/kg/q12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group;
EtoposideDrug
Also called Etoposide injection
100mg/m2/d for weighing >10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours
VenetoclaxDrug
Also called Venclexta
100mg/m2/d for weighing >10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd
Mitoxantrone hydrochloride liposomeDrug
Also called Mitoxantrone hydrochloride liposome injection
5mg/m2/d for weighing >10kg, 0.17mg/kg/d for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am.
Recombinant Human Granulocyte Colony-Stimulating FactorDrug
Also called Recombinant Human Granulocyte Colony-Stimulating Factor Injection
5ug/kg/d, d1-10, s.c., qd, at 1pm
Idarubicin HydrochlorideDrug
Also called Idarubicin hydrochloride injection
3mg/m2/day for weighing >10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.
SorafenibDrug
Also called Nexavar
100mg/m2/day for weighing >10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd
GilteritinibDrug
Also called Xospata Pill
20mg/m2/day for weighing >10kg, 0.7mg/kg/day for weighing ≤ 10kg, from identification, po, qd
AvapritinibDrug
Also called AYVAKIT
50mg/m2/day for weighing bodyweight >10kg, 1.65mg/kg/day for weighing ≤ 10kg, po, qd
| Study group | Role | What they receive |
|---|---|---|
| SDC group | Experimental | Patients with CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive SDC regimen, including one course of HAE (Homoharringtonine, cytarabine, etoposide) in induction I. These patients will continue on the SDC (HAE) regimen in the second course if the MRD is < 1% after induction I, otherwise venetoclax will be added to the SDC group sequentially on Day 2 after the end of HAE. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax. Receives: Drug: Homoharringtonine; Drug: Cytarabine; Drug: Etoposide; Drug: Venetoclax; Drug: Sorafenib; Drug: Gilteritinib; Drug: Avapritinib |
| LDC group | Experimental | Patients with the exception of the CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or those with the KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive the LDC (MAG/IDAG+ venetoclax) regimen in induction I. Patients with MRD ≥1% or KIT mutations, assessed after induction I, will receive the HAE plus venetoclax (or targeted drugs) regimen, otherwise, they will receive MAG/IDAG + venetoclax. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax. Receives: Drug: Cytarabine; Drug: Mitoxantrone hydrochloride liposome; Drug: Recombinant Human Granulocyte Colony-Stimulating Factor; Drug: Idarubicin Hydrochloride; Drug: Sorafenib; Drug: Gilteritinib; Drug: Avapritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CR/CRi with negative MRD
CR/CRi with negative MRD was defined as less than 5% blasts in bone marrow and MRD <0.1%.
Measured: Day 26 (HAE group) and Day 32 (MAG+Ven group) for remission induction 1 and 2 are the necessary time points for response evaluation.
Event-free survival
Events/failures of EFS include any-cause death, relapse, second malignancy, no CR after Indiction II and off-therapy due to abandonment or attending physician's decision.
Induction II and off-therapy due to abandonment or attending physician's decision.
Measured: From date of treatment until the date of the occurrence of the event, whichever comes first, assessed up to 72 months. Patients remaining event-free are censored at the last follow-up time.
Cumulative incidence of relapse
Failures of CIR only include relapse and no CR after Induction 2. Other failures including death in resission (before repalse), second malignancy, and off-therapy due to abandonment or attending physician's decision are considered competing risk.
Measured: From date of treatment until the date of when a failure of CIR occurs, whichever comes first, assessed up to 72 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, ChildhoodStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoyan Hu, Children's Hospital of Soochow University
- Investigators
- Shaoyan Hu, MD, PhD, Study chair, Children 's Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221683
- Sponsor's protocol ID
- GMCAII
- Acronym
- GMCAII
- Status last verified
- Aug 2024
- First submitted
- 4 Jan 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)
- ClinicalTrials.gov ID
- NCT06221683
- Acronym / sponsor ID
- GMCAII / GMCAII
- Conditions
- AML, Childhood, Acute Myeloid Leukemia
- Keywords
- AML, Childhood, Molecular subtyping, MRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Children's Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Jan 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.
The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR/CRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular/precision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.
Detailed description
Advances in risk stratification and therapy, have improved the event-free survival (EFS) and overall survival (OS) for pediatric acute myeloid leukemia (AML) with current treatment strategies. Investigators previously conducted a multicenter, randomized controlled trial (AML18) to compare the efficacy and safety of low-dose chemotherapy versus standard-dose chemotherapy. The results showed that low-dose chemotherapy was non-inferior to standard-dose chemotherapy in terms of efficacy and had fewer adverse events. However, different subtypes exhibited varying treatment responses to both chemotherapy regimens. The MRD (Measurable Residual Disease) after induction therapy in both groups had an impact on prognosis. According to the backbone of the 2018 protocol, investigators decide whether to use low-dose or standard-dose for the first induction according to the patient's fusion gene, and the second induction and subsequent treatment are adjusted according to the treatment response. Patients with the following 5 fusion genes RUNX1: RUNX1T1, CBFβ: MYH11, KMT2A: MLLT3 (AF9), KMT2A: MLLT10 (AF10), KMT2A: MLLT4 (AF6) fusion or KIT mutation will be assigned to the standard dose remission induction regimen (HHT + Ara-C + VP16), others will be assigned to the standard dose regimen (Mitoxantrone/Idarubicin + Ara-C + G-CSF). At the same time, investigators will add targeted drugs such as venetoclax, avaptitinib, and gilteritinib/sorafenib to the chemotherapy regimen and assess their safety and efficacy. Post-induction consolidation consisted of 3 to 4 cycles of standard-dose chemotherapy according to risk classification. Patients classified as high-risk are candidates for allogeneic bone marrow transplantation after 1 or 2 courses of consolidation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDC group | Experimental | Drug: Homoharringtonine, Drug: Cytarabine, Drug: Etoposide, Drug: Venetoclax, Drug: Sorafenib, Drug: Gilteritinib, Drug: AvapritinibPatients with CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive SDC regimen, including one course of HAE (Homoharringtonine, cytarabine, etoposide) in induction I. These patients will continue on the SDC (HAE) regimen in the second course if the MRD is < 1% after induction I, otherwise venetoclax will be added to the SDC group sequentially on Day 2 after the end of HAE. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax. |
| LDC group | Experimental | Drug: Cytarabine, Drug: Mitoxantrone hydrochloride liposome, Drug: Recombinant Human Granulocyte Colony-Stimulating Factor, Drug: Idarubicin Hydrochloride, Drug: Sorafenib, Drug: Gilteritinib, Drug: AvapritinibPatients with the exception of the CBF fusion gene (RUNX1: : RUNX1T1 and CBFB: : MYH11) or those with the KMT2A: : MLLT3(AF9) , KMT2A: : MLLT10(AF10) , KMT2A: : MLLT4(AF6) fusion gene or KIT mutation will receive the LDC (MAG/IDAG+ venetoclax) regimen in induction I. Patients with MRD ≥1% or KIT mutations, assessed after induction I, will receive the HAE plus venetoclax (or targeted drugs) regimen, otherwise, they will receive MAG/IDAG + venetoclax. FLT3-ITD will be given sorafenib or gilteritinib as early as possible, and patients with KIT mutations will be recommended to add avapritinib as appropriate. These targeted drugs will not be combined with venetoclax. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 1、Newly diagnosed, untreated AML；
- 2、Under 18 years old;
- 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg/m2 (50 mg/m2, q12h × 5d)；
- 4、 Liver function：Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min；Cardiac NYHA grading<3；SaO2>92%;
- 5、No active infection (symptoms resolved for more than 3 days if infected)
Key exclusion criteria (12 listed)
- 1、Acute megakaryocytic leukemia (AMKL)；
- 2、Acute promyelocytic leukemia (APL);
- 3、Treatment-related secondary AML and AML with definite MDS transformation；
- 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML);
- 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；
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 |
|---|---|---|
| HomoharringtonineAlso: Homoharringtonine injection3mg/m2/day for weighing >10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours | Drug | SDC group |
| CytarabineAlso: Cytosar100mg/m2/q12h for weighing >10kg, 3.3mg/kg/q12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg/m2/q12h for weighing >10kg, 0.33mg/kg/q12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group; | Drug | LDC group, SDC group |
| EtoposideAlso: Etoposide injection100mg/m2/d for weighing >10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours | Drug | SDC group |
| VenetoclaxAlso: Venclexta100mg/m2/d for weighing >10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd | Drug | SDC group |
| Mitoxantrone hydrochloride liposomeAlso: Mitoxantrone hydrochloride liposome injection5mg/m2/d for weighing >10kg, 0.17mg/kg/d for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am. | Drug | LDC group |
| Recombinant Human Granulocyte Colony-Stimulating FactorAlso: Recombinant Human Granulocyte Colony-Stimulating Factor Injection5ug/kg/d, d1-10, s.c., qd, at 1pm | Drug | LDC group |
| Idarubicin HydrochlorideAlso: Idarubicin hydrochloride injection3mg/m2/day for weighing >10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours. | Drug | LDC group |
| SorafenibAlso: Nexavar100mg/m2/day for weighing >10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd | Drug | LDC group, SDC group |
| GilteritinibAlso: Xospata Pill20mg/m2/day for weighing >10kg, 0.7mg/kg/day for weighing ≤ 10kg, from identification, po, qd | Drug | LDC group, SDC group |
| AvapritinibAlso: AYVAKIT50mg/m2/day for weighing bodyweight >10kg, 1.65mg/kg/day for weighing ≤ 10kg, po, qd | Drug | LDC group, SDC group |
Primary outcome
Rate of CR/CRi with negative MRD
Time frame: Day 26 (HAE group) and Day 32 (MAG+Ven group) for remission induction 1 and 2 are the necessary time points for response evaluation.
CR/CRi with negative MRD was defined as less than 5% blasts in bone marrow and MRD <0.1%.
Event-free survival
Time frame: From date of treatment until the date of the occurrence of the event, whichever comes first, assessed up to 72 months. Patients remaining event-free are censored at the last follow-up time.
Events/failures of EFS include any-cause death, relapse, second malignancy, no CR after Indiction II and off-therapy due to abandonment or attending physician's decision. Induction II and off-therapy due to abandonment or attending physician's decision.
Cumulative incidence of relapse
Time frame: From date of treatment until the date of when a failure of CIR occurs, whichever comes first, assessed up to 72 months.
Failures of CIR only include relapse and no CR after Induction 2. Other failures including death in resission (before repalse), second malignancy, and off-therapy due to abandonment or attending physician's decision are considered competing risk.
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 Aug 2024.
- 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.
Shaoyan Hu, MD, PhD study chair
Children 's Hospital of Soochow University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Homoharringtonine, Cytarabine and Etoposide in people with AML, Childhood and Acute Myeloid Leukemia, run by Children's Hospital of Soochow University at 13 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 8 inclusion and 12 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 Shaoyan Hu, MD, PhD (+86-13771870462, hsy139@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CR/CRi with negative MRD (time frame: Day 26 (HAE group) and Day 32 (MAG+Ven group) for remission induction 1 and 2 are the necessary time points for response evaluation.). The study lists 3 primary outcomes in all. 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 22 Aug 2024.