Clinical trial · Interventional
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Study of Depsipeptide, a Histone Deacetylase Inhibitor, in Relapsed or Refractory Mantle Cell or Diffuse Large Cell Non-Hodgkin's Lymphoma
NCT00383565CI-TRIAL-00014588terminatedPhase 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)
FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell to grow and by blocking blood flow to the cancer. This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| romidepsin | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.
- interventionNames
- Drug: romidepsin
Primary outcomes (1)
- measure
- Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment
- timeFrame
- 24 weeks (6 courses of 4 week cycles)
- description
- International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following subtypes: * Mantle cell lymphoma * Diffuse large cell lymphoma * (Ineligible for or unwilling to undergo stem cell transplantation) * Relapsed or refractory disease: * Any number of prior therapies allowed for relapsed disease, including peripheral blood stem cell or bone marrow transplantation * No more than 2 prior regimens, excluding monotherapy with monoclonal antibody or radiotherapy, for refractory disease * Measurable disease, defined as \>= 1 lesion \>= 1.5 cm in the longest diameter * No transformed lymphoma, defined as the transformation of a low-grade lymphoma, including follicular lymphoma or small lymphocytic lymphoma, to a high-grade lymphoma (e.g., diffuse large cell lymphoma) * ECOG performance status 0-2 * Absolute neutrophil count \>= 1,000/mm\^3 OR \>= 500/mm\^3 if extensive bone marrow involvement (\> 50%) or hypersplenism with palpable splenomegaly * Platelet count \>= 75,000/mm\^3 OR \>= 50,000/mm\^3 if extensive bone marrow involvement (\> 50%) or hypersplenism with palpable splenomegaly * Bilirubin normal * Alkaline phosphatase =\< 2 times upper limit of normal (ULN) * AST =\< 2 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant cardiac disease, including New York Heart Association class III-IV congestive heart failure * No history of serious ventricular arrhythmia * QTc \< 500 msec * No evidence of cardiac hypertrophy on ECG * No known HIV positivity * No other uncontrolled serious medical condition or active infection (e.g., chronic obstructive pulmonary disease, diabetes) * Recovered from prior therapy * No prior doxorubicin hydrochloride \>= 450 mg/m\^2 or mitoxantrone \>= 112 mg/m\^2 (Patients who received both mitoxantrone and doxorubicin hydrochloride should have a "doxorubicin equivalent dose" \< 450 mg/m\^2 * No prior therapy with a histone deacetylase inhibitor * No concurrent dexamethasone or prednisone except for refractory nausea/vomiting * No concurrent drugs associated with QTc prolongation (e.g., dolasetron mesylate) * Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided patient is receiving potassium chloride supplementation (No supplementation needed if switched to a potassium-conserving diuretic) * No CNS lymphoma * Creatinine normal * Cardiac function \>= 50% by MUGA
References
Publications (0)
Data not yet available
No reference posted for this study.