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

NCT ID: NCT02850822

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Myelodysplastic Syndrome Chemotherapy

Keywords

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chemotherapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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%).

Demethylation drug

Intervention Type DRUG

Demethylation drug,such as Decitabine

Chemotherapy regimen

Intervention Type DRUG

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.

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%).

No interventions assigned to this group

Interventions

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Demethylation drug

Demethylation drug,such as Decitabine

Intervention Type DRUG

Chemotherapy 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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifa Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qifa Liu

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qifa Liu

Role: CONTACT

Phone: 020-62787883

Email: [email protected]

Facility Contacts

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Li Xuan

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36905177 (View on PubMed)

Other Identifiers

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Therapy vs Notherapy-MDS-2016

Identifier Type: -

Identifier Source: org_study_id