Clinical trial · Interventional
Vorinostat in Treating Patients With Acute Myeloid Leukemia
A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Acute Myeloid Leukemia (AML)
NCT00305773CI-TRIAL-00014565completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells. This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemia.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Erythroid Leukemia (M6) | Adult Acute Erythroid Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation | ALIAS | 0.90 |
| Adult Acute Myeloblastic Leukemia Without Maturation (M1) | Adult Acute Myeloid Leukemia without Maturation | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (once daily vorinostat)
- description
- Patients receive oral vorinostat (SAHA) once a day on days 1-21. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: vorinostat
- type
- EXPERIMENTAL
- label
- Arm II (thrice daily vorinostat)
- description
- Patients receive oral SAHA three times a day on days 1-14. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: vorinostat
Primary outcomes (1)
- measure
- Confirmed Complete Response (CR) Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of acute myeloid leukemia (AML), meeting 1 of the following criteria:
* Relapsed AML in the following categories:
* Good-risk cytogenetics \[inv(16), t (8;21)\] in second relapse or in first relapse following a remission of \< 12 months
* Acute promyelocytic leukemia (M3) in second relapse or greater AND must have relapsed following both tretinoin-anthracycline-based therapy and arsenic trioxide-based therapy
* All other relapsed patients are eligible
* Untreated AML in the following categories:
* At least 65 years of age
* Myelodysplastic syndromes-AML (AML with trilineage dysplasia)
* AML with del5Q or monosomy 5, monosomy 7, or complex cytogenetics (≥ 3 cytogenetic abnormalities)
* Refused or ineligible for potentially curative options such as allogeneic stem cell transplantation
* No clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia
* ECOG performance status (PS) 0-2 or Karnofsky PS ≥ 60%
* Life expectancy ≥ 3 months
* Bilirubin normal unless attributed to hemolysis or Gilbert's disease in the opinion of the investigator
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
* No uncontrolled intercurrent illness, including any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would limit compliance with study requirements
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* More than 4 weeks since prior radiotherapy
* More than 2 weeks since prior valproic acid
* More than 3 weeks since other prior treatment for AML, including hematopoietic growth factors
* Hydroxyurea for WBC \> 30,000/mm\^3 allowed
* Recovered from prior therapy
* No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or darbepoetin alfa
* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies for this cancerReferences
Publications (1)
- DERIVEDSchaefer EW, Loaiza-Bonilla A, Juckett M, DiPersio JF, Roy V, Slack J, Wu W, Laumann K, Espinoza-Delgado I, Gore SD; Mayo P2C Phase II Consortium. A phase 2 study of vorinostat in acute myeloid leukemia. Haematologica. 2009 Oct;94(10):1375-82. doi: 10.3324/haematol.2009.009217. PMID 19794082