Clinical trial NCT03719534: Haplo HCT vs Haplo-cord HCT for Patients With AML
Official title: An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematopoietic Stem Cell Transplantation
Haplo-identical Donor
Cord Blood Unit
Acute Myeloid Leukemia
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: The Second People's Hospital of Huai'an
name: Soochow Hopes Hematology Hospital
name: Hygeia Suzhou Yongding Hospital
First posted: 2018-10-25
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall survival
timeFrame: 3 year after randomization
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 year after randomization
measure: Cumulative incidence of relapse
timeFrame: 3 year after randomization
measure: Cumulative incidence of non-relapse mortality
timeFrame: 3 year after randomization
Other outcomes:
Locations:
city: Huai'an
country: China
facility: The Second People's Hospital of Huai'an
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: Soochow Hopes Hematology Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Hygeia Suzhou Yongding Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: