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A Phase II Study of Depsipeptide, a Histone Deacetylase Inhibitor, in Relapsed or Refractory Mantle Cell or Diffuse Large Cell Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling
Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

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Trial Information

A Phase II Study of Depsipeptide, a Histone Deacetylase Inhibitor, in Relapsed or Refractory Mantle Cell or Diffuse Large Cell Non-Hodgkin's Lymphoma


I. Determine the response rate (complete and partial) to FR901228 in patients with relapsed
or refractory mantle cell or diffuse large cell non-Hodgkin's lymphoma.

II. Evaluate the safety and feasibility of FR901228, in terms of the incidence of toxicity
and maximum grade observed and courses delayed or dose reductions, in these patients.

III. Determine 2-year progression-free and overall survival.

OUTLINE: Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.

Treatment repeats every 28 days for at least 6 courses in the absence of disease progression
or unacceptable toxicity.

After completion of study treatment, patients are followed every 3-6 months for up to 5

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment

Outcome 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.

Outcome Time Frame:

24 weeks (6 courses of 4 week cycles)

Safety Issue:


Principal Investigator

Jorge Romaguera

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

Related Keywords:

  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell



M D Anderson Cancer Center Houston, Texas  77030