NCT06020833

Brief Summary

Roxadustat has been approved for low-risk MDS clinical trials, but the trial results are not available. For refractory low-risk MDS, the effective rate of roxadustat treatment is about 20-30%, and roxadustat combined with retinoic acid may have better efficacy in the treatment of refractory low-risk MDS.

Trial Health

45
At Risk

Trial Health Score

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

Timeline
4mo left

Started Aug 2023

Typical duration for phase_1

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Aug 2023Dec 2026

First Submitted

Initial submission to the registry

February 17, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 7, 2026

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

February 17, 2022

Last Update Submit

July 5, 2026

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • overall response rate (OR)

    Complete and partial remission with roxadustat combined with retinoic acid. Partial remission includes freedom from transfusion dependence or reduction in transfusion volume within 8 weeks

    3, 6 months

Study Arms (1)

Roxadustat combined with retinoic acid group

EXPERIMENTAL
Drug: Roxadustat in combination with retinoic acid

Interventions

Roxadustat in combination with retinoic acidDRUG

Roxadustat 150mg po qod combined with retinoic acid 20mg po bid

Roxadustat combined with retinoic acid group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low-risk MDS unresponsive to first-line therapy

You may not qualify if:

  • myelofibrosis
  • Severe heart and kidney function bu'quan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Carraway HE, Saygin C. Therapy for lower-risk MDS. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):426-433. doi: 10.1182/hematology.2020000127.

    PMID: 33275714BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

roxadustatTretinoin

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2022

First Posted

September 1, 2023

Study Start

August 1, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

July 7, 2026

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share