Trial · NCT00656617

Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

NCT00656617, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2015-03-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). Trials, record NCT00656617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00656617

On this page

Trial

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

Title: Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
NCT number: NCT00656617
Status: Completed
Phases: Phase 2
Enrollment: 106 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Interventions: Idarubicin, Cytarabine, Vorinostat
First posted: 2008-04-11
Last updated: 2015-03-09
Results first posted: 2015-03-09

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS) at 7 Months	PFS Evaluation at 7 months	Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.
Secondary	Participant Response	Monitoring with each 4 week cycle, up to 18 cycles of treatment	Number of participants with response assessed according RECIST: Complete Response (CR) defined as normalization of marrow (\< 5% blasts) and of peripheral blood counts (neutrophil count \> 1.109/L, platelet count \> 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by \>50% compared to pretreatment values but above \<5%. Complete Response without platelet recovery (CRp) = CR, but platelets \<100 x 109/L. Progressive disease (PD) defined as increase of blasts to \> 10% after an initial response.

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	Progression Free Survival (PFS) at 7 Months	PFS Evaluation at 7 months	Four (4) participants did not receive treatment therefore were not evaluable for outcome assessment.	percentage of participants	NUMBER
SECONDARY	Participant Response	Monitoring with each 4 week cycle, up to 18 cycles of treatment	Four (4) participants were not treated therefore not evaluable for the outcome assessment.	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Units
Progression Free Survival (PFS) at 7 Months	Idarubicin + Ara-C + Vorinostat		65	percentage of participants
Participant Response	Idarubicin + Ara-C + Vorinostat	Complete Response (CR)	67	participants
Participant Response	Idarubicin + Ara-C + Vorinostat	Partial Response (PR)	0	participants
Participant Response	Idarubicin + Ara-C + Vorinostat	Complete Response without platelet recovery (CRp)	11	participants
Participant Response	Idarubicin + Ara-C + Vorinostat	Progressive Disease (PD)	0	participants
Participant Response	Idarubicin + Ara-C + Vorinostat	No response	24	participants

Source ClinicalTrials.gov

Participant flow5

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Idarubicin + Ara-C + Vorinostat	106
Overall Study	Run-in Induction Phase	Idarubicin + Ara-C + Vorinostat	3
Overall Study	Induction Phase	Idarubicin + Ara-C + Vorinostat	103
Overall Study	COMPLETED	Idarubicin + Ara-C + Vorinostat	99
Overall Study	NOT COMPLETED	Idarubicin + Ara-C + Vorinostat	7

Source ClinicalTrials.gov

Adverse events104

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	Tinnitus	Ear and labyrinth disorders	Idarubicin + Ara-C + Vorinostat (Phase 1)	0	3	0
other	Tinnitus	Ear and labyrinth disorders	Idarubicin + Ara-C + Vorinostat (Phase 2)	1	99	1
other	Cardiac Arrhythmia-Other (Specify)	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 1)	0	3	0
other	Cardiac Arrhythmia-Other (Specify)	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 2)	6	99	6
other	Ventricular arrhythmia--Select	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 1)	0	3	0
other	Ventricular arrhythmia--Select	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 2)	1	99	1
other	Cardiac General-Other (Specify)	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 1)	0	3	0
other	Cardiac General-Other (Specify)	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 2)	2	99	2
other	Cardiac ischemia/infarction	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 1)	0	3	0
other	Cardiac ischemia/infarction	Cardiac disorders	Idarubicin + Ara-C + Vorinostat (Phase 2)	1	99	1

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Idarubicin + Ara-C + Vorinostat (Phase 1)
Total, all-cause mortality	Idarubicin + Ara-C + Vorinostat (Phase 2)
Total, other adverse events	Idarubicin + Ara-C + Vorinostat (Phase 1)	3	3
Total, other adverse events	Idarubicin + Ara-C + Vorinostat (Phase 2)	91	99
Total, serious adverse events	Idarubicin + Ara-C + Vorinostat (Phase 1)	0	3
Total, serious adverse events	Idarubicin + Ara-C + Vorinostat (Phase 2)	3	99

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

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

Comparison
Idarubicin + Ara-C + Vorinostat (Phase 1) vs Idarubicin + Ara-C + Vorinostat (Phase 2): serious adverse events

Source 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/NCT00656617

GET https://conductscience.org/api/trials/v1/NCT00656617/events?page=2

API reference For AI assistants