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Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT

NCT ID: NCT03530085

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2022-04-01

Brief Summary

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Detailed Description

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Conditions

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Acute Myeloid Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Conditioning Elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dec+Flu+Bu Conditioning Regimen

For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7；Fludarabine(Flu) 30mg/m2/day on days -6 to -3；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

Decitabine was administered at 20mg/m2/day on days -9 to -7.

Busulfan (BU)

Intervention Type DRUG

Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.

Fludarabine(Flu)

Intervention Type DRUG

Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.

Interventions

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Decitabine

Decitabine was administered at 20mg/m2/day on days -9 to -7.

Intervention Type DRUG

Busulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.

Intervention Type DRUG

Fludarabine(Flu)

Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* AML patients older than 60 years, younger than 80 years
* In complete remission before transplantation
* With HLA-matched sibling donors

Exclusion Criteria

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifa Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qifa Liu

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology,Nanfang Hospital

Locations

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Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Xuan

Role: CONTACT

Phone: 008615521251270

Email: [email protected]

Facility Contacts

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Li Xuan

Role: primary

References

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Liu Q, Hu Z, Xu N, Jiang Y, Fan Z, Huang F, Lin R, Jin H, Zeng Y, He H, Zhu P, Yu G, Shi P, Sun R, Xu X, Li Z, Zhang Y, Sun J, Wang Y, Xuan L. Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trial. Lancet Reg Health West Pac. 2025 Aug 12;61:101664. doi: 10.1016/j.lanwpc.2025.101664. eCollection 2025 Aug.

Reference Type DERIVED
PMID: 40831735 (View on PubMed)

Other Identifiers

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Dec+FB-Elderly AML-2018

Identifier Type: -

Identifier Source: org_study_id