Trial · NCT01720225

Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk

NCT01720225, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-12-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk. Trials, record NCT01720225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01720225

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
NCT number: NCT01720225
Status: Completed
Phases: Phase 2
Enrollment: 113 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Leukemia
Interventions: Decitabine, Azacitidine
First posted: 2012-11-02
Last updated: 2020-12-24
Results first posted: 2020-12-24

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With a Response	56 days	Overall Response = complete remission (CR) + partial remission (PR) + marrow CR (mCR) + hematologic improvement (HI). CR is normalization of peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 10\^9/L, and platelet count \> 100 x 10\^9/L). PR is same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Marrow CR is blasts \</= 5% and decreased by \>/=50% from baseline. HI is platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pre-therapy; or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 X1 0\^9/L.
Secondary	Number of Participants Who Became Transfusion Independent	8 weeks	Participants who were transfusion dependent at baseline prior to starting therapy on the Decitabine or Azacitidine arm will be analyzed for transfusion independence. Transfusion independence defined as being transfusion-free for ≥8 consecutive weeks between the first dose and study treatment discontinuation.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants With a Response	56 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Became Transfusion Independent	8 weeks	Participants analyzed for Transfusion Independence must have been transfusion dependent at baseline. Thirty-seven participants in the Decitabine arm and nineteen participants in the Azacitidine arm where transfusion dependent prior to treatment on this study.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Participants With a Response	Decitabine	49	Participants
Participants With a Response	Azacitidine	19	Participants
Number of Participants Who Became Transfusion Independent	Decitabine	12	Participants
Number of Participants Who Became Transfusion Independent	Azacitidine	3	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Decitabine	73
Overall Study	STARTED	Azacitidine	40
Overall Study	COMPLETED	Decitabine	70
Overall Study	COMPLETED	Azacitidine	39
Overall Study	NOT COMPLETED	Decitabine	3
Overall Study	NOT COMPLETED	Azacitidine	1

Source ClinicalTrials.gov

Adverse events120

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Decitabine	11	73	11
other	Nausea	Gastrointestinal disorders	Azacitidine	6	40	6
other	Fatigue	General disorders	Decitabine	6	73	6
other	Fatigue	General disorders	Azacitidine	4	40	4
other	Constipation	Gastrointestinal disorders	Decitabine	3	73	3
other	Constipation	Gastrointestinal disorders	Azacitidine	6	40	6
other	Diarrhea	Gastrointestinal disorders	Decitabine	2	73	2
other	Diarrhea	Gastrointestinal disorders	Azacitidine	3	40	3
serious	Acute Kidney Injury	Renal and urinary disorders	Decitabine	1	73	1
serious	Acute Kidney Injury	Renal and urinary disorders	Azacitidine	0	40	0

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Decitabine	7	73
Total, all-cause mortality	Azacitidine	2	40
Total, other adverse events	Decitabine	20	73
Total, other adverse events	Azacitidine	16	40
Total, serious adverse events	Decitabine	32	73
Total, serious adverse events	Azacitidine	14	40

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28774880	DERIVED	PubMed
38319837	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Decitabine vs Azacitidine: Participants With a Response	Trial comparisons
Decitabine vs Azacitidine: Number of Participants Who Became Transfusion Independent	Trial comparisons
Decitabine vs Azacitidine: deaths from any cause	Trial comparisons
Decitabine vs Azacitidine: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01720225

GET https://conductscience.org/api/trials/v1/NCT01720225/events?page=2

API reference For AI assistants