Suspended

Vorinostat and Azacitidine Combination for Myelodysplastic Syndromes and Select Acute Myeloid Leukemia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the safety and effectiveness of combining Vorinostat and Azacitidine in treating Myelodysplastic Syndromes and select Acute Myeloid Leukemia, by observing the frequency and severity of toxicities and assessing the overall response proportion in patients.

What is being tested

Azacitidine

+ Laboratory Biomarker Analysis

+ Pharmacological Study

DrugOther
Who is being recruted

Anemia+18

+ Anemia, Refractory

+ Anemia, Refractory, with Excess of Blasts

Over 18 Years
+35 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: November 2006
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 22, 2006

Actual date on which the first participant was enrolled.

This study aims to evaluate the safety and effectiveness of a drug combination for treating myelodysplastic syndromes (MDS), a group of diseases where the bone marrow doesn't produce enough healthy blood cells. The study also includes some patients with acute myeloid leukemia (AML), a type of cancer that affects the blood and bone marrow. The drugs involved are Vorinostat [Suberoylanilide Hydroxamic Acid (SAHA)] and Azacitidine. The goal is to find the right doses of these drugs that can be safely used together over time. The study also hopes to understand how this treatment affects patients' DNA and blood cell development, and how it impacts the progression of MDS. During the study, participants receive Azacitidine as an injection under the skin once daily for seven days, and Vorinostat as an oral medication two to three times daily for a specific period. This treatment cycle repeats every 28 days for at least four courses, as long as the disease doesn't worsen or cause severe side effects. The study monitors the frequency of side effects and the overall response to the treatment. After the treatment, patients are followed up monthly for six months, and then every two months thereafter.

Official TitleA Phase 1/2 Study of Vorinostat [Suberoylanilide Hydroxamic Acid (SAHA)] in Combination With Azacitidine in Patients With the Myelodysplastic Syndrome (MDS)
NCT00392353
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

135 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, RefractoryAnemia, Refractory, with Excess of BlastsBone Marrow DiseasesChronic DiseaseLeukemia, Erythroblastic, AcuteHematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, Megakaryoblastic, AcuteLeukemia, MyeloidMyelodysplastic SyndromesMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, ChronicDisease AttributesMyelodysplastic-Myeloproliferative Diseases

Criteria

24 inclusion criteria required to participate
Patients with low risk MDS (IPSS Score < 0.5) must additionally meet criteria as outlined for patients with refractory anemia or refractory anemia with ring sideroblasts above
No prior treatment with azacitidine, decitabine or vorinostat
Total bilirubin =\<= 1.5 x upper limit of normal (ULN); unless the patient has active hemolysis, or the elevation is secondary to ineffective erythropoiesis
Eligibility Criteria for the phase I portion (step 1); patients must have a diagnosis of either MDS according to French-American-British (FAB) and International Prognostic Scoring System (IPSS) criteria, or a diagnosis of AML according to FAB or World Health Organization (WHO) criteria
Show More Criteria
11 exclusion criteria prevent from participating
Active systemic bacterial, fungal of viral infection; infection should be fully treated and the patient afebrile for 7 days before study entry
Patients who have had chemotherapy or radiotherapy within 12 months prior to entering the study or those with another malignancy who have had evidence of the malignancy during the 3 years prior to study entry
Prior treatment with G-CSF, GM-CSF, or other hematopoietic growth factors, erythropoietin within one month prior to study; no interferon or retinoids within one month prior to study
Prior history of leukemia (step 2 phase II component of the study only)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive azacitidine SC QD on days 1-7 and vorinostat PO 2-3 times daily on days 3-5, 3-9, or 3-16. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

NYP/Weill Cornell Medical Center

New York, United StatesOpen NYP/Weill Cornell Medical Center in Google Maps
Suspended

University of Chicago Comprehensive Cancer Center

Chicago, United States
Suspended

University of Maryland/Greenebaum Cancer Center

Baltimore, United States
Suspended

North Shore University Hospital

Manhasset, United States
Suspended7 Study Centers