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A multicenter, prospective, single-arm, exploratory study of the efficacy of autologous transplantation in Low-risk and intermediate-risk AML patients (non-M3, age <65y) with MRD negative after induction chemotherapy

A multicenter, prospective, single-arm, exploratory study of the efficacy of autologous transplantation in Low-risk and intermediate-risk AML patients with MRD negative after induction chemotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056167
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-01-18
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-risk and intermediate-risk acute myeloid leukemia

Interventions

autologous transplantation:conditioning

Sponsors

Institute of Hematology and Blood Diseases Hospital,CAMS & PUMC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Low and medium risk AML patients diagnosed by bone marrow cell morphology, immunology and genetics; 2. Aged < 65 years, male or female; 3. One course of induction chemotherapy reaches CRMRD -; 4. The physical condition assessment (ECOG-PS) of the eastern oncology collaboration group was 0-2 points; 5. The informed consent form must be signed before the start of the study procedure. For patients aged 18 years and above, the informed consent form should be signed by the patient himself or his immediate family members. For children and adolescents under the age of 18, the informed consent form should be signed by the legal guardian. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family member shall sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Central nervous system leukemia; 2. With extramedullary infiltration; 3. Have a history of other tumors and have received any treatment for this tumor in the past 3 years; 4. Serological reaction of HIV or active hepatitis C virus is known to be positive; 5. Those suffering from mental illness or other conditions cannot cooperate with the requirements of research, treatment and monitoring; 6. Active heart disease is defined as one or more of the following: history of uncontrolled or symptomatic angina pectoris; Myocardial infarction less than 6 months from the time of study; A history of arrhythmias requiring medication or with severe clinical symptoms; Uncontrolled or symptomatic congestive heart failure (>NYHA grade 2); Ejection fraction is lower than the lower limit of the normal range; 7. The researcher thinks it is not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
disease-free survival;relapse rate;transplant related mortality;

Countries

China

Contacts

Public ContactWang Jianxiang, Jiang Erlie

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC?

jiangerlie@ihcams.ac.cn+86 22 23909020, +86 15122538106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026