Haplo-SCT vs ASCT With or Without Decitabine in AML CR1

NCT ID: NCT02059720

Last Updated: 2020-02-05

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

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2020-12-31

Brief Summary

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A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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auto

patients receive autologous SCT

Group Type ACTIVE_COMPARATOR

HSCT

Intervention Type PROCEDURE

Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.

haplo

patients receive haplo-SCT

Group Type ACTIVE_COMPARATOR

HSCT

Intervention Type PROCEDURE

Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.

Interventions

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HSCT

Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18y
* Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time
* Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)
* Presence of an available haplo-mismatch related donor

Exclusion Criteria

* Contra-indications of chemotherapy or hematopoietic stem cell transplantation
* Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor
* Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT
* No effective contraception
* Pregnant or lactating females
* Other causes which are not suitable for the trial in investigator's consideration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society for Blood and Marrow Transplantation

NETWORK

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Depei Wu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

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The Fisrt Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Depei Wu, M.D., Ph.D.

Role: CONTACT

+86 512 67781856

Jia Chen, M.D.

Role: CONTACT

+86 512 67781856

Facility Contacts

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Depei Wu, M.D., Ph.D.

Role: primary

+86 512 6778 1856

Jia Chen, M.D.

Role: backup

+86 512 6778 1856

Other Identifiers

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ChiCTR-TRC-14004196

Identifier Type: REGISTRY

Identifier Source: secondary_id

SZ3702

Identifier Type: -

Identifier Source: org_study_id

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