Effect of Chemotherapy vs No Chemotherapy Pre-transplant to MDS Undergoing Allo-HSCT

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02850822

Enrollment

250

Registered

2016-08-01

Start date

2016-07-31

Completion date

2020-06-30

Last updated

2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome, Chemotherapy

Keywords

chemotherapy

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.

Interventions

DRUGDemethylation drug

Demethylation drug,such as Decitabine

DRUGChemotherapy regimen

Chemotherapy regimen,such as CAG, G-CSF 5-10ug/kg/day on days 4 and 17；Aclacinomycin 7mg/m2/day on days 4 and 11；Cytarabine 20mg/m2/day on days 4 and 17.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
overall survival (OS)	2 year

Secondary

Measure	Time frame
relapse rate	2 year
disease-free survival (DFS)	2 year
transplant-related mortality (TRM)	2 year

Countries

China

Contacts

Primary ContactQifa Liu

liuqifa628@163.com020-62787883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026