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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

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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) in patients with relapsed or
refractory Burkitt's, mantle cell or diffuse large cell non-Hodgkin's lymphoma treated with
FR901228 (depsipeptide).

II. Determine the safety and feasibility of this drug, in terms of incidence and maximum
grade of toxicity and courses delayed or doses reduced, in these patients.

III. Determine the 2-year progression-free survival and overall survival of patients treated
with this drug.

IV. Correlate tumor expression of BCL-2, BCL-6, BAX, and RAS with response in patients
treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) 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.

Patients are followed every 3 months until disease progression and then every 6 months until
5 years from study registration.

Inclusion Criteria


- Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the
following cellular types:

- Diffuse large cell

- Mantle cell

- Burkitt's

- Relapsed or refractory disease

- No more than 2 prior regimen for patients with refractory disease

- Any number of prior therapies (including peripheral blood stem cell or bone
marrow transplantation) allowed for patients with relapsed disease provided
there was an objective response to the most recent therapy

- Measurable disease

- At least 1 lesion ≥ 1.5 cm in diameter

- No transformed lymphoma

- No CNS lymphoma

- Ineligible for, refused, or relapsed after stem cell transplantation



- 18 and over

Performance status

- ECOG 0-2


- Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 in patients with extensive bone
marrow involvement [> 50%] or hypersplenism with palpable splenomegaly)

- Platelet count ≥ 75,000/mm^3 (50,000/mm^3 in patients with extensive bone marrow
involvement or hypersplenism with palpable splenomegaly)


- Bilirubin ≤ upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2 times ULN

- AST ≤ 2 times ULN


- Creatinine ≤ ULN


- QTc < 500 msec by ECG

- Cardiac function ≥ 50% by MUGA

- No prior serious ventricular arrhythmia

- No New York Heart Association class III or IV congestive heart failure

- No significant cardiac hypertrophy by ECG

- No other significant cardiac disease


- No chronic obstructive pulmonary disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No active infection

- No diabetes

- No other uncontrolled serious medical condition



- Prior cumulative doxorubicin dose < 450 mg/m^2

- Prior cumulative mitoxantrone dose < 112 mg/m^2

- Prior doxorubicin equivalent dose < 450 mg/m^2 (for patients who have previously
received both doxorubicin and mitoxantrone)


- Recovered from all prior therapy

- No prior histone deacetylase inhibitor therapy

- No concurrent medication associated with QTc prolongation, such as dolasetron

- Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided
patient is on concurrent potassium chloride supplementation

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Nancy L. Bartlett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent mantle cell lymphoma
  • recurrent adult Burkitt lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Howard University Cancer Center at Howard University Hospital Washington, District of Columbia  20060