Phase 2
Completed N=37
Vorinostat in Treating Patients With Acute Myeloid Leukemia
leukemia · Refractory Cytopenia With Multilineage Dysplasia
Source: ClinicalTrials.gov NCT00305773 ↗
Enrolled (actual)
37
Serious AEs
70.3%
Results posted
May 2013
Primary outcomePrimary: Confirmed Complete Response (CR) Rate — 0; 4.5 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Complete Response (CR) Rate |
0; 4.5 | — |
| SECONDARY Time to Progression (TTP) |
— | — |
| SECONDARY Overall Survival (OS) |
105; 153 | — |
| SECONDARY Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events |
10; 17 | — |
Eligibility Criteria
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 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 cancer
Data sourced from ClinicalTrials.gov (NCT00305773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.