Clinical trial · Interventional
FR901228 in Treating Patients With Hematologic Cancer
A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)
NCT00024180CI-TRIAL-00009216completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| romidepsin | Drug | Romidepsin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following hematologic malignancies:
* Chronic lymphocytic leukemia (CLL)
* Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)
* Acute myeloid leukemia (AML)
* Acute lymphoblastic leukemia (ALL)
* Stratum I (CLL and SLL):
* Received at least one prior therapy containing a purine analog OR
* Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy
* Stratum II (AML and ALL):
* Primary refractory or relapsed leukemia within the past year that is not amenable to curative therapy
* OR
* Untreated or previously treated poor-risk leukemia defined by any of the following:
* 65 years of age and over
* Poor-risk candidates for aggressive chemotherapy
* Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Stratum I only:
* No uncontrolled autoimmune hemolytic anemia
* No idiopathic thrombocytopenic purpura
* Stratum II only:
* WBC no greater than 10,000/mm\^3 OR
* WBC no greater than 40,000/mm\^3 that is stable for at least 1 week (may be sustained by hydroxyurea through the first week of study)
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* ALT and AST no greater than 3 times upper limit of normal
Renal:
* Creatinine less than 2.0 mg/dL
Cardiovascular:
* Ejection fraction at least 50% by MUGA
* No myocardial infarction or unstable angina within the past 6 months
* No prior unstable ventricular or supraventricular cardiac arrhythmias
Other:
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other medical or psychiatric problem that would preclude study
* Stratum I only:
* No active infection requiring oral or IV antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 28 days since prior chemotherapy (except hydroxyurea)
* At least 6 weeks since prior nitrosoureas
* At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM)
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* At least 28 days since prior radiotherapy
Surgery:
* At least 28 days since prior major surgeryReferences
Publications (1)
- RESULTByrd JC, Marcucci G, Parthun MR, Xiao JJ, Klisovic RB, Moran M, Lin TS, Liu S, Sklenar AR, Davis ME, Lucas DM, Fischer B, Shank R, Tejaswi SL, Binkley P, Wright J, Chan KK, Grever MR. A phase 1 and pharmacodynamic study of depsipeptide (FK228) in chronic lymphocytic leukemia and acute myeloid leukemia. Blood. 2005 Feb 1;105(3):959-67. doi: 10.1182/blood-2004-05-1693. Epub 2004 Oct 5. PMID 15466934