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:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT00069966
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
* Any stage, with or without B symptoms
* The following subtypes are eligible:
* Diffuse large cell (B and T cell types)
* Anaplastic large cell
* Diffuse mixed cell
* Immunoblastic large cell
* Follicular large cell
* Transformed follicular NHL
* Diffuse aggressive not otherwise classified
* Burkitt-like lymphoma
* Bone marrow positive or negative
* At least 1 measurable lesion
* Patients with bone marrow as the only site of disease are eligible without a measurable lesion
* No more than 1 episode of progressive disease, occurring after a response (complete response \[CR\], complete response unconfirmed \[CR\_u\], or partial response \[PR\]) to prior chemotherapy\* NOTE: \*Patients with less than a CR, CRu, or PR and no progression, but who are good candidates for high-dose chemotherapy with stem cell support may be eligible (will be decided on an individual basis)
* No chemotherapy-refractory disease, defined as follows:
* Stable or progressive disease documented at restaging immediately after the completion of induction therapy
* No lymphoblastic lymphoma, or mantle cell lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
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 clearly due to bone marrow involvement by lymphoma
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*
* AST or ALT no greater than 2.0 times ULN\*
* Alkaline phosphatase no greater than 2.0 times ULN\*
* No history or clinical symptoms of hepatitis B or hepatitis C virus
* Patients with seropositivity due to prior vaccination for hepatitis B are eligible NOTE: \*Higher values may be accepted if clearly due to liver involvement by lymphoma
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 grade II-IV cardiovascular disease
* No myocardial infarction within the past 6 months
* No severe cardiac arrhythmia
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* HIV negative
* No clinically significant neurological abnormalities
* No condition that would preclude study safety or interfere with study results
* No concurrent serious uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior rituximab immediately after the first chemotherapy regimen allowed
Chemotherapy
* See Disease Characteristics
* See Biologic therapy
* At least 6 months since prior anthracycline therapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone \[CHOP\])
* More than 2 years since prior fludarabine
* More than 2 years since prior nitrosoureas
* More than 1 year since prior platinum-based chemotherapy or cytarabine, unless a CR or CR\_u was achieved
* No prior cumulative dose of cisplatin greater than 600 mg/m\^2
* No prior single or cumulative dose of doxorubicin greater than 450 mg/m\^2
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the whole pelvis
* No prior radioimmunotherapy
Surgery
* More than 4 weeks since prior major thoracic and/or abdominal surgery
* At least 1 week since prior minor surgery
Other
* Recovered from prior therapy
* Alopecia allowed
* Grade 1 peripheral neuropathy allowed
* More than 30 days since prior participation in another investigational drug study
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00069966
Study Brief:
Protocol Section:
NCT00069966