Clinical trial NCT02487069: Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
Official title: Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Chronic Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Guangzhou General Hospital of Guangzhou Military Command
name: Guangzhou First People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Zhujiang Hospital
name: Tongji Hospital
name: Wuhan Union Hospital, China
name: Fujian Medical University Union Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Xiangya Hospital of Central South University
First posted: 2015-07-01
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.

Detailed description: Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary disease is acute leukemia/MDS/CML
* Receiving allo-HSCT

Exclusion Criteria:

* cardiac dysfunction (particularly congestive heart failure)
* hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* renal dysfunction (creatinine clearance rate \< 30 mL/min)
* 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)

Primary outcomes:
measure: Overall Survival
timeFrame: 3 year
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 year
measure: Incidence of transplantation-related mortality
timeFrame: 3 year
measure: Incidence of graft-versus-host disease
timeFrame: 3 year
measure: Incidence of infection
timeFrame: 3 year
measure: hematopoietic reconstruction
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo Y, Xiao H, Lai X, Shi J, Tan Y, He J, Xie W, Zheng W, Zhu Y, Ye X, Yu X, Cai Z, Lin M, Huang H. T-cell-replete haploidentical HSCT with low-dose anti-T-lymphocyte globulin compared with matched sibling HSCT and unrelated HSCT. Blood. 2014 Oct 23;124(17):2735-43. doi: 10.1182/blood-2014-04-571570. Epub 2014 Sep 11.
citation: Lu DP, Dong L, Wu T, Huang XJ, Zhang MJ, Han W, Chen H, Liu DH, Gao ZY, Chen YH, Xu LP, Zhang YC, Ren HY, Li D, Liu KY. Conditioning including antithymocyte globulin followed by unmanipulated HLA-mismatched/haploidentical blood and marrow transplantation can achieve comparable outcomes with HLA-identical sibling transplantation. Blood. 2006 Apr 15;107(8):3065-73. doi: 10.1182/blood-2005-05-2146. Epub 2005 Dec 27.