Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT

NCT ID: NCT04216355

Last Updated: 2020-01-03

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

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2023-12-31

Brief Summary

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This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .

Detailed Description

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Conditions

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MDS-EB

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZA with CAG derived regimen

Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC)

Group Type EXPERIMENTAL

Azacitidine

Intervention Type DRUG

Low-dose AZA

CAG Protocol

Intervention Type DRUG

Short term CAG derived regimen

Interventions

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Azacitidine

Low-dose AZA

Intervention Type DRUG

CAG Protocol

Short term CAG derived regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
* Recipient of an allogeneic hematopoietic stem cell transplantation
* Age \< 65 years
* ECOG performance status ≤2
* Written informed consent
* No psychological, familial, social, or geographic reason that would compromise clinical follow up

Exclusion Criteria

* Relapsed or refractory advanced MDS
* Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
* Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
* Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
* A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ting YANG

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Yang, Prof.M.D.Ph.D

Role: CONTACT

86-591-86218441

Facility Contacts

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Ting Yang, Prof.

Role: primary

+86-591-83357896 ext. 8041

Jianda Hu, Prof.

Role: backup

+86-591-83357896 ext. 8041

Other Identifiers

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MDS-SCT-01

Identifier Type: -

Identifier Source: org_study_id

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