Oral Azacitidine for Myelodysplastic Syndrome

Local Institution - 0141, Hangzhou, China
Myelodysplastic SyndromeOral Azacitidine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test how well azacitidine works in treating people with MDS.

Eligible Conditions
  • Myelodysplastic Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

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5-azacytidine
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SEA-CD70
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NIS793

Study Objectives

3 Primary · 25 Secondary · Reporting Duration: Up to 5 years after discontinuation of Investigational Product, approximately 6 years

Year 1
Best
CR duration
Iron parameters measured from blood
Platelet Transfusion
Number of participants who achieved pRBC transfusion reduction
Number of participants who achieved platelet-transfusion independence (PLT-TI) as per IWG 2006 criteria
Number of participants with healthcare resource use associated with the investigational product (IP)
OR duration
PLT-TI duration
modCR duration
pRBC transfusion reduction duration
pRBC-TI duration
Up to 16 weeks
Number of participants who achieved First Overall Response (OR)
Up to 24 weeks
Number of participants who achieved OR within 6 cycles, defined as modCR, PR, mCR, HI-E, HI-P, HI-N as per IWG 2006 criteria
Number of participants who achieved Overall Response (OR) per IWG 2006 criteria within 6 cycles
Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
Number of participants who achieved modCR
Number of participants who achieved modified complete response (modCR) within 6 cycles
Up to 32 weeks
Number of participants who achieved 56-day packed red blood cells-transfusion independence (pRBC-TI) as per IWG 2006 criteria
Blood Transfusion
Year 6
Event-free Survival (EFS)
Overall Survival (OS)
Time to acute myeloid leukemia (AML)
Time to subsequent therapy
Year 1
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
Summary statistics for Functional Assessment of Cancer Therapy-Anemia (FACT-An) scales and subscales at each assessment point for each treatment arm
Summary statistics for Quality of Life in Myelodysplasia Scale (QUALMS) scales and subscales at each assessment point for each treatment arm
Summary statistics for the EuroQol 5 Dimension 5 Level (EQ-5D-5L) scales and subscales at each assessment point for each treatment arm

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
5-azacytidine
1
SEA-CD70
1
NIS793

Trial Design

4 Treatment Groups

Part II - Oral-Aza (RP3D)
1 of 4
Part I - Oral-Aza (Dose 2)
1 of 4
Part II - Placebo
1 of 4
Part I - Oral-Aza (Dose 1)
1 of 4

Experimental Treatment

230 Total Participants · 4 Treatment Groups

Primary Treatment: Oral Azacitidine · Has Placebo Group · Phase 2 & 3

Part II - Oral-Aza (RP3D)
Drug
Experimental Group · 1 Intervention: Oral Azacitidine · Intervention Types: Drug
Part I - Oral-Aza (Dose 2)
Drug
Experimental Group · 1 Intervention: Oral Azacitidine · Intervention Types: Drug
Part II - Placebo
Drug
Experimental Group · 1 Intervention: Placebo for Oral Azacitidine · Intervention Types: Drug
Part I - Oral-Aza (Dose 1)
Drug
Experimental Group · 1 Intervention: Oral Azacitidine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Azacitidine
2007
Completed Phase 1
~200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years after discontinuation of investigational product, approximately 6 years

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,537 Previous Clinical Trials
4,019,037 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What aim does this particular clinical trial have?

"The aim of this trial, which will run for 24 weeks, is to see the number of participants who achieve remission as defined by the 2006 IWG criteria. Other measures of success include secondary outcomes like CR and OR duration (both in Phase 2 and 3) as well as Number of participants who become platelet transfusion independent within 6 cycles." - Anonymous Online Contributor

Unverified Answer

In how many places can patients sign up for this trial?

"7 sites are running this clinical trial, which are situated in locations including Portland, Charlotte and East Syracuse. To reduce the amount of travel needed, patients are encouraged to select the site closest to their location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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