Clinical trial NCT02850822: Effect of Chemotherapy vs No Chemotherapy Pre-transplant to MDS Undergoing Allo-HSCT
Official title: Effect of Chemotherapy vs No Chemotherapy Pre-transplantation for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS (Bone Marrow Blast Cells Less Than 50%) Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndrome
Chemotherapy
Keywords: chemotherapy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Fujian Medical University Union Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Zhujiang Hospital
name: Guangzhou First People's Hospital
First posted: 2016-08-01
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RAEB-1, REAB-2 and AML Secondary to MDS (Bone marrow blast cells less than 50%) undergoing allo-HSCT

Brief summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Detailed description: Allo-HSCT appears to be an efficient tool to cure patients with MDS and AML secondary to MDS. Decitabine and/or chemotherapy pre-transplantation could reduce the blast cells in bone marrow and improve the complete remission rate. However, decitabine and/or chemotherapy had side effects and might increase treatment-related mortality. At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Eligibility criteria: Inclusion Criteria:

* RAEB-1, REAB-2 and AML Secondary to MDS (Bone marrow blast cells less than 50%) undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* 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 (OS)
timeFrame: 2 year
Secondary outcomes:
measure: relapse rate
timeFrame: 2 year
measure: disease-free survival (DFS)
timeFrame: 2 year
measure: transplant-related mortality (TRM)
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou, Guangdong, China, 510515
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References: