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

Soochow University

Status and phase: Unknown; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Procedure: HSCT

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02059720

SZ3702

ChiCTR-TRC-14004196 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

auto

Active Comparator group

Description:

patients receive autologous SCT

Treatment:

Procedure: HSCT

haplo

Active Comparator group

Description:

patients receive haplo-SCT

Treatment:

Procedure: HSCT