Trial · NCT01522976

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

NCT01522976, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2016-03-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia. Trials, record NCT01522976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01522976

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Trial

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

Title: Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
NCT number: NCT01522976
Status: Active not recruiting
Phases: Phase 2
Enrollment: 282 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Chronic Myelomonocytic Leukemia, Chronic Myelomonocytic Leukemia-1, Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Myelodysplastic Syndrome With Excess Blasts-1, Myelodysplastic Syndrome/Acute Myeloid Leukemia
Interventions: Azacitidine, Laboratory Biomarker Analysis, Lenalidomide, Vorinostat
First posted: 2012-02-01
Last updated: 2026-09-09
Results first posted: 2016-03-22

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Response Rate (Phase II)	Up to 5 years	A response is any of complete hematological remission, partial remission, or hematologic improvement.
Primary	Overall Survival (Phase III)	Up to 5 years	OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.
Secondary	Relapse-free Survival	Up to 5 years	RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.
Secondary	Overall Survival	Up to 5 years	OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow- up for patients last known to be alive is censored at the date of last contact. OS will be estimated for each of the three arms using the Kaplan-Meier method.
Secondary	Pre-study Cytogenetic Abnormalities	Up to 5 years	Cytogenetic risk group is used to identify cytogenetic abnormalities.
Secondary	Toxicity Rate	Up to 5 years	Adverse events that are possibly, probably or definitely related to study drug are reported.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rate (Phase II)	Up to 5 years	Analysis includes eligible patients only.	percentage of patients having a response	NUMBER
PRIMARY	Overall Survival (Phase III)	Up to 5 years	This trial did not proceed to the Phase III portion. Therefore, no patients were analyzed for this outcome measure.
SECONDARY	Relapse-free Survival	Up to 5 years	Analysis includes eligible patients who had a response.	Days	MEDIAN
SECONDARY	Overall Survival	Up to 5 years	Analysis includes eligible patients only.	Days	MEDIAN
SECONDARY	Pre-study Cytogenetic Abnormalities	Up to 5 years	Analysis includes eligible patients only.	participants	NUMBER
SECONDARY	Toxicity Rate	Up to 5 years	Analysis includes only eligible patients who also received treatment.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group312

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

Outcome	Group	Category	Value	Spread	Units
Response Rate (Phase II)	Arm 1: Azacitidine/Lenalidomide		49	95% Confidence Interval 39 to 60	percentage of patients having a response
Response Rate (Phase II)	Arm 2: Azacitidine		38	95% Confidence Interval 28 to 49	percentage of patients having a response
Response Rate (Phase II)	Arm 3: Azacitidine/Vorinostat		27	95% Confidence Interval 18 to 37	percentage of patients having a response
Relapse-free Survival	Arm 1: Azacitidine/Lenalidomide		435	95% Confidence Interval 237 to 546	Days
Relapse-free Survival	Arm 2: Azacitidine		311	95% Confidence Interval 182 to 640	Days
Relapse-free Survival	Arm 3: Azacitidine/Vorinostat		455	95% Confidence Interval 197 to NA	Days
Overall Survival	Arm 1: Azacitidine/Lenalidomide		588	95% Confidence Interval 426 to 737	Days
Overall Survival	Arm 2: Azacitidine		449	95% Confidence Interval 356 to 603	Days
Overall Survival	Arm 3: Azacitidine/Vorinostat		527	95% Confidence Interval 392 to 852	Days
Pre-study Cytogenetic Abnormalities	Arm 1: Azacitidine/Lenalidomide	Good/very good	35		participants

1 to 10 of 312Source ClinicalTrials.gov

See all 312 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1: Azacitidine/Lenalidomide	97
Overall Study	STARTED	Arm 2: Azacitidine	92
Overall Study	STARTED	Arm 3: Azacitidine/Vorinostat	93
Overall Study	COMPLETED	Arm 1: Azacitidine/Lenalidomide	0
Overall Study	COMPLETED	Arm 2: Azacitidine	0
Overall Study	COMPLETED	Arm 3: Azacitidine/Vorinostat	0
Overall Study	NOT COMPLETED	Arm 1: Azacitidine/Lenalidomide	97
Overall Study	NOT COMPLETED	Arm 2: Azacitidine	92
Overall Study	NOT COMPLETED	Arm 3: Azacitidine/Vorinostat	93

Source ClinicalTrials.gov

Adverse events645

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
other	Anemia	Blood and lymphatic system disorders	Arm 1: Azacitidine/Lenalidomide	76	89
other	Anemia	Blood and lymphatic system disorders	Arm 2: Azacitidine	71	91
other	Anemia	Blood and lymphatic system disorders	Arm 3: Azacitidine/Vorinostat	72	91
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm 1: Azacitidine/Lenalidomide	13	89
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm 2: Azacitidine	14	91
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm 3: Azacitidine/Vorinostat	13	91
other	Chest pain - cardiac	Cardiac disorders	Arm 1: Azacitidine/Lenalidomide	3	89
other	Chest pain - cardiac	Cardiac disorders	Arm 2: Azacitidine	2	91
other	Chest pain - cardiac	Cardiac disorders	Arm 3: Azacitidine/Vorinostat	6	91
other	Sinus tachycardia	Cardiac disorders	Arm 1: Azacitidine/Lenalidomide	3	89

1 to 10 of 645Source ClinicalTrials.gov

See all 645 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1: Azacitidine/Lenalidomide
Total, all-cause mortality	Arm 2: Azacitidine
Total, all-cause mortality	Arm 3: Azacitidine/Vorinostat
Total, other adverse events	Arm 1: Azacitidine/Lenalidomide	88	89
Total, other adverse events	Arm 2: Azacitidine	89	91
Total, other adverse events	Arm 3: Azacitidine/Vorinostat	91	91
Total, serious adverse events	Arm 1: Azacitidine/Lenalidomide	37	89
Total, serious adverse events	Arm 2: Azacitidine	8	91
Total, serious adverse events	Arm 3: Azacitidine/Vorinostat	47	91

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29618479	DERIVED

Source PubMed

Grants2

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180888	SWOG Network Group Operations Center of the NCTN	LARA, PRIMO N.; HERSHMAN, DAWN	UNIVERSITY OF CALIFORNIA AT DAVIS	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons0

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

None in this release.

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.

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