Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00077194
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Hematopoietic
* 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)
Hepatic
* Bilirubin ≤ upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 times ULN
* AST ≤ 2 times ULN
Renal
* Creatinine ≤ ULN
Cardiovascular
* 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
Pulmonary
* No chronic obstructive pulmonary disease
Other
* 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 CONCURRENT THERAPY:
Chemotherapy
* 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)
Other
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00077194
Study Brief:
Protocol Section:
NCT00077194