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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT00053105
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following:
* Diffuse large B-cell lymphoma
* Transformed NHL
* Follicular large cell lymphoma
* Peripheral T-cell lymphoma
* Unclassified aggressive histology (immunoblastic lymphoma)
* Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m\^2)
* No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 to 64
Performance status
* WHO 0-1
Life expectancy
* At least 3 months
Hematopoietic
* Neutrophil count at least 1,500/mm\^3\*
* Platelet count at least 100,000/mm\^3\* NOTE: \*Lower values may be accepted if evidence of bone marrow involvement
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*\*
* Alkaline phosphatase no greater than 2 times ULN\*\*
* AST or ALT no greater than 2 times ULN\*\*
* No history or clinical symptoms of hepatitis B or C virus NOTE: \*\*Higher values may be accepted if evidence of liver involvement
Renal
* Creatinine no greater than 1.5 mg/dL
Cardiovascular
* LVEF at least 50% by MUGA
* No clinically significant cardiovascular abnormalities
* No New York Heart Association class II-IV heart disease
* No myocardial infarction within the past 6 months
* No severe arrhythmia
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 6 months after study
* No history or clinical symptoms of HIV
* No clinically significant neurological abnormalities
* No serious uncontrolled infection (NCI CTC grade 3-4)
* No condition that would place the patient at undue risk or interfere with the study results
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 months since prior radioimmunotherapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* At least 1 year since prior platinum or cytarabine (unless complete response to treatment)
* At least 2 years since prior fludarabine or nitrosoureas
* No prior cumulative cisplatin greater than 600 mg/m\^2
Endocrine therapy
* Not specified
Radiotherapy
* See Biologic therapy
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to the whole pelvis
Surgery
* At least 1 week since prior minor surgery and recovered
* At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered
Other
* At least 1 month since prior investigational drugs
* Recovered from prior therapy
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00053105
Study Brief:
Protocol Section:
NCT00053105