NCT02850822

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 8, 2017

Status Verified

July 1, 2016

Enrollment Period

2.9 years

First QC Date

July 20, 2016

Last Update Submit

December 6, 2017

Conditions

Myelodysplastic SyndromeChemotherapy

Keywords

chemotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival (OS)

    2 year

Secondary Outcomes (3)

  • relapse rate

    2 year

  • disease-free survival (DFS)

    2 year

  • transplant-related mortality (TRM)

    2 year

Study Arms (2)

Therapy pre-transplantation

Chemotherapy regimen and/or demethylation drugs(such as decitabine) were given pre-transplantation for patients with RAEB-1, REAB-2 and AML Secondary to MDS (bone marrow blast cells less than 50%).

Drug: Demethylation drugDrug: Chemotherapy regimen

No Therapy pre-transplantation

No therapy (chemotherapy or demethylation drugs) was given pre-transplantation for patients with RAEB-1, REAB-2 and AML Secondary to MDS (bone marrow blast cells less than 50%).

Interventions

Demethylation drugDRUG

Demethylation drug,such as Decitabine

Therapy pre-transplantation
Chemotherapy regimenDRUG

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.

Therapy pre-transplantation

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

  • Pan D, Zhao W, Jiang Q, Yin C, He H, Liao L, Ye J, Dai M. Wilms' tumor 1 expression combined with genetic mutations for prognostic assessment in MDS. Leuk Lymphoma. 2023 Apr;64(4):856-864. doi: 10.1080/10428194.2023.2185086. Epub 2023 Mar 11.

    PMID: 36905177DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Qifa Liu

    Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou, Guangdong, China, 510515

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qifa Liu

CONTACT

020-62787883liuqifa628@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2016

First Posted

August 1, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

December 8, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)