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Recruiting NCT07131059

NCT07131059 MRD-positive AML Clinical Study

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Clinical Trial Summary
NCT ID NCT07131059
Status Recruiting
Phase —
Sponsor Institute of Hematology & Blood Diseases Hospital, China
Condition AML, Adult
Study Type INTERVENTIONAL
Enrollment 537 participants
Start Date 2024-05-11
Primary Completion 2028-05-10

Eligibility & Interventions

Sex All sexes
Min Age 14 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
IvosidenibGilteritinibVenetoclax

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 537 participants in total. It began in 2024-05-11 with a primary completion date of 2028-05-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.

Eligibility Criteria

Inclusion Criteria: * AML (non-M3) compliant with WHO (2016) standards; * In morphological complete remission. * Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive. * Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. 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. Exclusion Criteria: * Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks * The diagnosis is APL * Those who were not considered suitable for inclusion by the researchers.

Contact & Investigator

Central Contact

Hui Wei, Doctor

✉ weihui@ihcams.ac.cn

📞 13132507161

Principal Investigator

Huui Wei, doctor

PRINCIPAL INVESTIGATOR

Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Frequently Asked Questions

Who can join the NCT07131059 clinical trial?

This trial is open to participants of all sexes, aged 14 Years or older, studying AML, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07131059 currently recruiting?

Yes, NCT07131059 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.

Where is the NCT07131059 trial being conducted?

This trial is being conducted at Tianjin, China.

Who is sponsoring the NCT07131059 clinical trial?

NCT07131059 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Huui Wei, doctor at Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. The trial plans to enroll 537 participants.

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