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Acute Myeloid Leukemia in ChildrenNCT06233526

Individualized Treatment of Pediatric R/R AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test

A study testing Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test in people with Acute Myeloid Leukemia in Children, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute myeloid leukemia (AML) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after… Read more about this study

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for
Acute Myeloid Leukemia in Children
What is being tested?
Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Jan 2024to 31 Dec 2025
Phase
Interventional
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 Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • (1) Refractory recurrent acute myeloid leukemia (AML), and after second-line reinduction therapy, such as C+HAG did not reach complete CR.Criteria for complete response, refractory, and recurrence are as follows.
  • <18 years old; (3) The child had good organ function, could tolerate chemotherapy, and had a physical strength score of 0-3 (WHO standard); (4) Understand the research procedures and voluntarily sign written informed consent.

Who cannot join

  • (1) Acute promyelocytic leukemia, chronic myelogenous leukemia, acute mixed cell leukemia or known central nervous system leukemia; (2) AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Cole's syndrome, or congenital aplastic anemia; (3) secondary to immunodeficiency or positive for human immunodeficiency virus (HIV); (4) Cardiac and renal function were obviously abnormal, and left ventricular ejection fraction was <50%.
  • There is active systemic infection; (6) any medical history or concomitant condition that the investigator believes would impair the subject's safe completion of the study; (7) The investigator considers that the subject is medically unfit to receive the investigational drug or is unfit for any other reason; (8) a known or suspected allergy to the subject drug or to any drug administered in connection with this test;

Trial locations and contacts

1 site in 1 country.

Xiaojun Xu, MD contact

+8657188873617

xuxiaojun@zju.edu.cn

Meidan Ying, PhD contact

+8657188208401

mying@zju.edu.cn

China1 site, 1 recruiting

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Xu Xiaojun, chief physician, +86571888736617, xuxiaojun@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Individualized Treatment of Pediatric Relasped and Refractory Acute Myeloid Leukemia Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test

Acute myeloid leukemia (AML) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after hematopoietic stem cell transplantation).Relapsed/refractory (R/R) AML is a major cause of treatment failure and refractory survival. Reinduction chemotherapy for R/R-AML to obtain CR again, followed by hematopoietic stem cell transplantation, is the current treatment. At present, there is no recognized reinduction protocol, and the reinduction remission rate of R/R-AML varies greatly among different treatment regimens, ranging from 23 to 81%. Current guidelines recommend a new combination chemotherapy regimen consisting of new drugs without cross-resistance. This method selects sensitive chemotherapeutic drugs, and then forms a new combination chemotherapy regimen according to the characteristics of drugs, which is the choice of R/R-AML reinduction therapy.This study intends to conduct a clinical study on the individualized treatment of R/R AML patients through in vitro drug sensitivity test combined with patient transcriptomic characteristics.

Being tested
Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test
Keywords
Acute myeloid leukemia, relapsed/refractory, transcriptomic sequencing, drug sensitivity test
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

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

  • Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity testOther

    1. Leukemia cells from newly diagnosed and relapsed children with AML were tested for high throughput in vitro drug sensitivity and resistance.
    2. Combined with multi-omics sequencing technology such as whole exome and transcriptome, the data of drug sensitivity, drug resistance and genomic characteristics of children AML patients were integrated, and the internal rules between drug sensitivity or drug resistance and molecular characteristics such as gene fusion, gene mutation and abnormal gene expression of children AML patients were deeply analyzed, and the molecular characteristics of drug sensitivity in children AML were mapped
Study groups in NCT06233526
Study groupRoleWhat they receive
Individualized treatment groupExperimentalTreating the R/R AML patients based on the transcriptomic profile and in vitro drug sensitivity Test
Receives: Other: Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test

What is being measured

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

  1. Complete remission rate

    Complete remission rate after the course of individualized treatment

    Measured: 4 weeks

  2. Event free survival

    The patient's event free survival at one and five years after treatment

    Measured: one year, five years

Secondary outcomes (1)

  1. Overall Survival

    The patient's overall survival at one and five years after treatment

    Measured: one year, five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06233526
Sponsor's protocol ID
2023-IRB-0315-P-01
Status last verified
Jun 2024
First submitted
23 Jan 2024
Last updated
3 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Newell LF, Cook RJ. Advances in acute myeloid leukemia. BMJ. 2021 Oct 6;375:n2026. doi: 10.1136/bmj.n2026.

    PubMed 34615640

  • Kim H. Treatments for children and adolescents with AML. Blood Res. 2020 Jul 31;55(S1):S5-S13. doi: 10.5045/br.2020.S002.

    PubMed 32719170

  • Zarnegar-Lumley S, Caldwell KJ, Rubnitz JE. Relapsed acute myeloid leukemia in children and adolescents: current treatment options and future strategies. Leukemia. 2022 Aug;36(8):1951-1960. doi: 10.1038/s41375-022-01619-9. Epub 2022 Jun 6.

    PubMed 35668109

  • Leukemia & Lymphoma Group, Chinese Society of Hematology, Chinese Medical Association. [Chinese guidelines for the diagnosis and treatment of relapsed/refractory acute myelogenous leukemia (2021)]. Zhonghua Xue Ye Xue Za Zhi. 2021 Aug 14;42(8):624-627. doi: 10.3760/cma.j.issn.0253-2727.2021.08.002. No abstract available. Chinese.

    PubMed 34547866

  • Kamens JL, Nance S, Koss C, Xu B, Cotton A, Lam JW, Garfinkle EAR, Nallagatla P, Smith AMR, Mitchell S, Ma J, Currier D, Wright WC, Kavdia K, Pagala VR, Kim W, Wallace LM, Cho JH, Fan Y, Seth A, Twarog N, Choi JK, Obeng EA, Hatley ME, Metzger ML, Inaba H, Jeha S, Rubnitz JE, Peng J, Chen T, Shelat AA, Guy RK, Gruber TA. Proteasome inhibition targets the KMT2A transcriptional complex in acute lymphoblastic leukemia. Nat Commun. 2023 Feb 13;14(1):809. doi: 10.1038/s41467-023-36370-x.

    PubMed 36781850

  • Du W, Xia Z, Luo Z, Chen Y, Bing S, Wang W, Zhang X, Zhou Z, Zhang J, Cao J, Yang B, He Q, Shao X, Xu X, Ying M. A novel gene fusion RUNX1/ZNF423 promotes leukemic relapse of NUP98-rearranged AML. Leukemia. 2023 Nov;37(11):2286-2291. doi: 10.1038/s41375-023-02024-6. Epub 2023 Sep 15. No abstract available.

    PubMed 37714925

Questions about this trial

What is this clinical trial studying?

A study testing Chemotherapy regiments based on the transcriptomic profile and in vitro drug sensitivity test in people with Acute Myeloid Leukemia in Children, run by The Children's Hospital of Zhejiang University School of Medicine 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 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 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.

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 Xiaojun Xu, MD (+8657188873617, xuxiaojun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT06233526, which also lists 6 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 3 Jul 2024.

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