Haplo HCT vs Haplo-cord HCT for Patients With AML

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2023-03-31

Brief Summary

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Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.

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Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplantation Haplo-identical Donor Cord Blood Unit 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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Haplo-HCT

people enrolled in this arm will receive a typical haploidentical donor HCT

Group Type ACTIVE_COMPARATOR

haplo-HCT

Intervention Type PROCEDURE

HCT will be performed with a haploidentical donor

Haplo-cord HCT

people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT

Group Type EXPERIMENTAL

haplo-cord HCT

Intervention Type PROCEDURE

Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit

Interventions

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haplo-HCT

HCT will be performed with a haploidentical donor

Intervention Type PROCEDURE

haplo-cord HCT

Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 to 60 years old;
2. Patients with AML;
3. With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR)
4. Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor
5. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
6. Signing informed consent form, having the ability to comply with study and follow-up procedures

Exclusion Criteria

1. Acute promyelocytic leukaemia (AML subtype M3)
2. With other malignances
3. Failing to acquire a suitable UCB unit
4. With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy
5. With uncontrolled infection intolerant to haplo-HCT
6. With severe organ dysfunction

* Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
* Respiratory failure (PaO2≤60 mmHg)
* Hepatic abnormalities (total bilirubin≥2×upper limit of normal \[ULN\], alanine aminotransferase or aspartate aminotransferase≥2×ULN)
* Renal dysfunction (creatinine≥2 mg/dL creatinine clearance rate \< 30 mL/min)
7. In pregnancy or lactation period
8. With any conditions not suitable for the trial (investigators' decision)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No