Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Promyelocytic Leukemia (M3), Recurrent Adult Acute Myeloid Leukemia

In brief

This phase II trial is studying how well romidepsin works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Key facts

Study ID: NCT00062075
Run by: National Cancer Institute (NCI)
People needed: 47
Starts: 2003-05-01
Last updated by the study team: 2015-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed acute myeloid leukemia (AML) defined by the WHO classification
Initial diagnosis with either of the following:
Bone marrow or peripheral blood myeloblasts of at least 20%,
Recurring genetic abnormalities (e.g., t[8;21], inv 16, or t[16;16]) and
Bone marrow blast percentage less than 20%
Relapsed or refractory disease defined by 1 of the following:
Under 60 years of age and in second relapse or greater,
Over 60 years of age and in first relapse,
Acute promyelocytic leukemia that has relapsed despite prior tretinoin and arsenic therapy,
Primary refractory AML for which no standard therapy exists
Patients who are over 60 years of age with previously untreated disease and who refuse conventional chemotherapy are eligible
Patients who are over 60 years of age and in first relapse and poor medical candidates for reinduction chemotherapy or who refuse conventional chemotherapy are eligible
Not medically appropriate for OR refused curative bone marrow or stem cell transplantation
No CNS leukemia
ECOG 0-2 OR Karnofsky 60-100%
LVEF at least 40% by MUGA
QTc interval less than 500 msec by EKG
No myocardial infarction within the past 3 months
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior allergic reactions attributed to compounds of similar chemical or biological composition to FR901228 (depsipeptide)

Where it is running

University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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