Leukemia, Monocytic, AcutePhase 2/3SCCLG-M5NCT05313958
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children
A Phase 2/3 study testing Cladribine, G-CSF and Cytarabine in people with Leukemia, Monocytic, Acute and Pediatric AML, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 9 sites in China.
Trial summary
This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Leukemia, Monocytic, Acute, Pediatric AML
- What is being tested?
- Cladribine, G-CSF and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 9 sitesChina
- Study dates
- 1 Dec 2021to 30 Mar 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 0-14 years old
- Cytologically proven acute monocytic leukemia (M5) with other treatment
Who cannot join
- Secondary to immunodeficiency or MDS
- Second tumor
- Dowm's syndrome
- Evolution of chronic myelogenous leukemia to blast crisis
- Death or quit treatment in seven days at the begining of induction therapy
- Treatment with other effective chemotherapy drugs for AML, excluding the low dose chemotherapy for the purpose of reducing leukocytes in hyperleukocytic leukemia
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled heart, brain, liver and kidney failure etc.)
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Second Xiangya Hospital of Central South University
Changsha, Hunan
wuqing wan, 13507316963, wanwuqing65@163.com
- Recruiting
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong
riling chen, M.D, 19820318067, chenrl319@163.com
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong
lina wang, M.D, 18922234317, wanglina_11@yeah.net
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
yawei zhou, M.D, 136423337577, zywyhscg@qq.com
- Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
huiqin chen, M.D, 13724819908, chenhuiqinchq@126.com
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
lihua yang, M.D, 13580532469, yanglihua@163.com
- Recruiting
Jiangxi Province Children's Hospital Southern Medical University, China
Nanchang, Jiangxi
changda liang, M.D, 13879175309, liangchangda@163.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
qiwen chen, M.D, 13970807656, 13970807656@163.com
- Recruiting
Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong
beiyan wu, M.D, 13802336066, 1261305798@qq.com
About this study
Official title: Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children： A Prospective Multicenter Study in South China
This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3.
Read the detailed description
PRIMARY OBJECTIVES
1.To study the 3 year-overall survival of newly diagnosed monocytic leukemia treated with Cladribine and cytarabine in children.
SECONDARY OBJECTIVES
- To describe the complete response rate following CLAG (cladribine, cytarabine and granulocyte stimulating factor) in newly diagnosed monocytic leukemia in children for intensive induction therapy.
- To evaluate the 3-year progression-free survival in response to CLAG in children.
- To assess the toxicity of CLAG including cumulative infection incidence, cumulative adverse effects and chemotherapy-related mortality (TRD).
- To study the progression-free survival and overall survival (1 year, 2 year and 3 year) of newly diagnosed monocytic leukemia with positive FLT3 treated with CLAG in children and the side effects of sorafenib.
OUTLINE:
- The induction phase includes two parts including induction therapy I(CLAG) and induction therpay II(CLAG+I/M).
- The diagnosis and classified criteria is according to the 2016 WHO classification criteria for hematopoietic and lymphoid tissue tumors, and the consolidation therapy consists the therapeutic phases as the NOPHO-AML 2004 protocol prescribed. INDUCTION THERAPY I: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5 and granulocyte stimulating factor 5ug/kg/day on day 0-6. When blood count recover(WBC>2.0×109/L， ANC1.0×109/L、PLT≥50×109/L) , Patients achieving a morphological leukemia free state (< 5% blasts) or MRD< 1% receive a second course treatment as above. INDUCTION THERPAY II: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5, mitoxantrone/idarubicin 10mg/m2/day on day 1-3 and granulocyte stimulating factor 5ug/kg/day on day 0-6. Patients achieving blast count≥5% or MRD ≥1% proceed to induction II therpy.
- For FLT3 positive acute monocytic leukemia children, sorafenib 200mg/m2/day was taken orally until molecular biology remission for 2 years.
- After two courses of indution phase, patients with incomplete response（MRD≥0.1%）are recommended into hematopoietic stem cell transplantation.
- After two courses of indution phase, patients with persisting positive adverse prognosis cytogenetic abnormalities are recommended into hematopoietic stem cell transplantation.
Patients must meet one of the following risk criteria:
Standard-risk (SR) group meeting all of the following criteria:
Initial WBC < 10,000/μL
M1 (<5%) blasts or MRD<1% in bone marrow after the first course of induction therapy
M1 (<5%) blasts or MRD<0.1% in bone marrow after two courses of induction therapy
Cytogenetic abnormalities with good prognosis
Intermediate-risk (IR) group meeting the following criteria:
Lack of low-risk and high-risk conditions
High-risk (HR) group meeting ≥ 1 of the following criteria:
M2/M3(≥5%) blasts or MRD>5% in bone marrow after the first course of induction therapy
MRD≥0.1% in bone marrow after two course of induction therapy
Cytogenetic abnormalities with poor prognosis
- Conditions
- Leukemia, Monocytic, Acute, Pediatric AML
- Being tested
- Cladribine, G-CSF, Cytarabine, Idarubicin, Mitoxantrone
- Keywords
- Acute monocytic leukemia, pediatric, Cladribine, sorafenib
- Medical subject headings
- Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CladribineDrug
Also called cladribine injection
5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine
G-CSFDrug
Also called granulocyte
5ug/kg/day d0-5,if Peripheral blood leukocytes<20,000/ul
CytarabineDrug
Also called Ara-C
2g/㎡/day d1-5 in 4 hours, after the use of Cladribine
IdarubicinDrug
Also called Idamycin, IDA
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
MitoxantroneDrug
Also called MIT
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
SorafenibDrug
Also called sorafinib, Nexavar, sorafenib tosylate
200mg/m2/day was taken orally until molecular biology remission for 2 years
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | The patients in this arm will receive SCCLG-M5 2022 regimen for newly dignosed acute monocytic leukemia (M5) ,including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period and followed by three courses(HA1M, HA2E, HA3) in consolidation therapy prescribed as the NOPHO-AML 2004 protocol.
The targeted drugs sorafenib 200mg/m2/day orally is used for FLT3 positive acute monocytic leukemia until molecular biology remission for 2 years. Receives: Drug: Cladribine; Drug: G-CSF; Drug: Cytarabine; Drug: Idarubicin; Drug: Mitoxantrone; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
TOS was defined as time from diagnostic date through the date of death due to any reasons. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered.
Measured: 3 years
Secondary outcomes (3)
Induced remission rate (CR)
According to the time point specified in the treatment plan (22 days after the end of induction I, 29-43 days after the end of induction II and before each consolidation scheme) bone marrow puncture and lumbar puncture were performed. The follow-up contents included the detection of the count of primitive / immature lymphocytes and flow MRD. If there was a positive gene at the onset, the quantitative monitoring of the gene should be performed as MRD data at the same time. If the gene cannot be analyzed quantitatively, PCR qualitative analysis should still be performed as the monitoring basis
Measured: 3 years
Safety,including cumulative infection incidence, adverse reaction and chemotherapy-related mortality (TRD)
During treatment, closely monitor relevant laboratory tests, register adverse reaction records, and report the records according to the requirements of CRF form.
Measured: 3 years
Event-free survival (EFS)
EFS was estimated from date of diagnosis until date of one of the following events: relapse, refractory disease, second malignancy or death from any reason.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Dec 2021
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Monocytic, AcuteStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Maternal and Child Health Hospital of Foshan, The First Affiliated Hospital of Guangzhou Medical University, Second Xiangya Hospital of Central South University, Jiangxi Province Children's Hospital, Southern Medical University, China, The First Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital, First Affiliated Hospital of Shantou University Medical College
- Responsible party
- Sponsor
- Investigators
- dunha zhou, M.D, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313958
- Sponsor's protocol ID
- 2021-KY-052
- Other IDs
- 2021A1515011809
- Acronym
- SCCLG-M5
- Status last verified
- Jul 2023
- First submitted
- 26 Dec 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu LP, Zhang AL, Ruan M, Chang LX, Liu F, Chen X, Qi BQ, Zhang L, Zou Y, Chen YM, Chen XJ, Yang WY, Guo Y, Zhu XF. Prognostic stratification of molecularly and clinically distinct subgroup in children with acute monocytic leukemia. Cancer Med. 2020 Jun;9(11):3647-3655. doi: 10.1002/cam4.3023. Epub 2020 Mar 26.
PubMed 32216042Weis TM, Marini BL, Bixby DL, Perissinotti AJ. Clinical considerations for the use of FLT3 inhibitors in acute myeloid leukemia. Crit Rev Oncol Hematol. 2019 Sep;141:125-138. doi: 10.1016/j.critrevonc.2019.06.011. Epub 2019 Jun 28.
PubMed 31279288Rubnitz JE, Crews KR, Pounds S, Yang S, Campana D, Gandhi VV, Raimondi SC, Downing JR, Razzouk BI, Pui CH, Ribeiro RC. Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. Leukemia. 2009 Aug;23(8):1410-6. doi: 10.1038/leu.2009.30. Epub 2009 Feb 26.
PubMed 19242495
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children： A Prospective Multicenter Study in South China
- ClinicalTrials.gov ID
- NCT05313958
- Acronym / sponsor ID
- SCCLG-M5 / 2021-KY-052
- Conditions
- Leukemia, Monocytic, Acute, Pediatric AML
- Keywords
- Acute monocytic leukemia, pediatric, Cladribine, sorafenib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Maternal and Child Health Hospital of Foshan, The First Affiliated Hospital of Guangzhou Medical University, Second Xiangya Hospital of Central South University, Jiangxi Province Children's Hospital, Southern Medical University, China, The First Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital, First Affiliated Hospital of Shantou University Medical College
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 6 Apr 2022 (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 is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3.
Detailed description
PRIMARY OBJECTIVES
1.To study the 3 year-overall survival of newly diagnosed monocytic leukemia treated with Cladribine and cytarabine in children.
SECONDARY OBJECTIVES
- To describe the complete response rate following CLAG (cladribine, cytarabine and granulocyte stimulating factor) in newly diagnosed monocytic leukemia in children for intensive induction therapy.
- To evaluate the 3-year progression-free survival in response to CLAG in children.
- To assess the toxicity of CLAG including cumulative infection incidence, cumulative adverse effects and chemotherapy-related mortality (TRD).
- To study the progression-free survival and overall survival (1 year, 2 year and 3 year) of newly diagnosed monocytic leukemia with positive FLT3 treated with CLAG in children and the side effects of sorafenib.
OUTLINE:
- The induction phase includes two parts including induction therapy I(CLAG) and induction therpay II(CLAG+I/M).
- The diagnosis and classified criteria is according to the 2016 WHO classification criteria for hematopoietic and lymphoid tissue tumors, and the consolidation therapy consists the therapeutic phases as the NOPHO-AML 2004 protocol prescribed. INDUCTION THERAPY I: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5 and granulocyte stimulating factor 5ug/kg/day on day 0-6. When blood count recover(WBC>2.0×109/L， ANC1.0×109/L、PLT≥50×109/L) , Patients achieving a morphological leukemia free state (< 5% blasts) or MRD< 1% receive a second course treatment as above. INDUCTION THERPAY II: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5, mitoxantrone/idarubicin 10mg/m2/day on day 1-3 and granulocyte stimulating factor 5ug/kg/day on day 0-6. Patients achieving blast count≥5% or MRD ≥1% proceed to induction II therpy.
- For FLT3 positive acute monocytic leukemia children, sorafenib 200mg/m2/day was taken orally until molecular biology remission for 2 years.
- After two courses of indution phase, patients with incomplete response（MRD≥0.1%）are recommended into hematopoietic stem cell transplantation.
- After two courses of indution phase, patients with persisting positive adverse prognosis cytogenetic abnormalities are recommended into hematopoietic stem cell transplantation.
Patients must meet one of the following risk criteria:
Standard-risk (SR) group meeting all of the following criteria:
Initial WBC < 10,000/μL
M1 (<5%) blasts or MRD<1% in bone marrow after the first course of induction therapy
M1 (<5%) blasts or MRD<0.1% in bone marrow after two courses of induction therapy
Cytogenetic abnormalities with good prognosis
Intermediate-risk (IR) group meeting the following criteria:
Lack of low-risk and high-risk conditions
High-risk (HR) group meeting ≥ 1 of the following criteria:
M2/M3(≥5%) blasts or MRD>5% in bone marrow after the first course of induction therapy
MRD≥0.1% in bone marrow after two course of induction therapy
Cytogenetic abnormalities with poor prognosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Cladribine, Drug: G-CSF, Drug: Cytarabine, Drug: Idarubicin, Drug: Mitoxantrone, Drug: SorafenibThe patients in this arm will receive SCCLG-M5 2022 regimen for newly dignosed acute monocytic leukemia (M5) ,including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period and followed by three courses(HA1M, HA2E, HA3) in consolidation therapy prescribed as the NOPHO-AML 2004 protocol. The targeted drugs sorafenib 200mg/m2/day orally is used for FLT3 positive acute monocytic leukemia until molecular biology remission for 2 years. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 0-14 years old
- Cytologically proven acute monocytic leukemia (M5) with other treatment
Key exclusion criteria (8 listed)
- Secondary to immunodeficiency or MDS
- Second tumor
- Dowm's syndrome
- Evolution of chronic myelogenous leukemia to blast crisis
- Death or quit treatment in seven days at the begining of induction therapy
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 |
|---|---|---|
| CladribineAlso: cladribine injection5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine | Drug | treatment arm |
| G-CSFAlso: granulocyte5ug/kg/day d0-5,if Peripheral blood leukocytes<20,000/ul | Drug | treatment arm |
| CytarabineAlso: Ara-C2g/㎡/day d1-5 in 4 hours, after the use of Cladribine | Drug | treatment arm |
| IdarubicinAlso: Idamycin, IDAIdarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II | Drug | treatment arm |
| MitoxantroneAlso: MITIdarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II | Drug | treatment arm |
| SorafenibAlso: sorafinib, Nexavar, sorafenib tosylate200mg/m2/day was taken orally until molecular biology remission for 2 years | Drug | treatment arm |
Primary outcome
Overall survival (OS)
Time frame: 3 years
TOS was defined as time from diagnostic date through the date of death due to any reasons. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered.
3 secondary outcomes
Induced remission rate (CR)
Time frame: 3 years
Safety,including cumulative infection incidence, adverse reaction and chemotherapy-related mortality (TRD)
Time frame: 3 years
Event-free survival (EFS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 32216042Liu LP, Zhang AL, Ruan M, Chang LX, Liu F, Chen X, Qi BQ, Zhang L, Zou Y, Chen YM, Chen XJ, Yang WY, Guo Y, Zhu XF. Prognostic stratification of molecularly and clinically distinct subgroup in children with acute monocytic leukemia. Cancer Med. 2020 Jun;9(11):3647-3655. doi: 10.1002/cam4.3023. Epub 2020 Mar 26.
- Results publication: PubMed 31279288Weis TM, Marini BL, Bixby DL, Perissinotti AJ. Clinical considerations for the use of FLT3 inhibitors in acute myeloid leukemia. Crit Rev Oncol Hematol. 2019 Sep;141:125-138. doi: 10.1016/j.critrevonc.2019.06.011. Epub 2019 Jun 28.
- Results publication: PubMed 19242495Rubnitz JE, Crews KR, Pounds S, Yang S, Campana D, Gandhi VV, Raimondi SC, Downing JR, Razzouk BI, Pui CH, Ribeiro RC. Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. Leukemia. 2009 Aug;23(8):1410-6. doi: 10.1038/leu.2009.30. Epub 2009 Feb 26.
- Individual participant dataSharing planned: No
Related trials for Leukemia, Monocytic, Acute
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Active, not recruitingPhase 2
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia
RecruitingPhase 2
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
Acute Leukemia, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
Acute Biphenotypic Leukemia, Acute Leukemia
RecruitingPhase 2
Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
Acute Myeloid Leukemia, Essential Thrombocythemia
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. This study is not recruiting at the moment.
dunha zhou, M.D study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cladribine, G-CSF and Cytarabine in people with Leukemia, Monocytic, Acute and Pediatric AML, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 9 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dunhua zhou, M.D (13560099258, zdunhua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 3 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 NCT05313958, which also lists 3 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 27 Jul 2023.