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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00416351
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed T-cell or natural killer (NK)-cell lymphoma, including any of the following subtypes:
* Blastic NK-cell lymphoma
* T/NK-cell lymphoma/leukemia
* Adult T-cell lymphoma/leukemia
* T-cell prolymphocytic leukemia
* T-lymphoblastic lymphoma
* Peripheral T-cell lymphoma, not otherwise specified
* Angioimmunoblastic T-cell lymphoma
* Anaplastic large cell lymphoma
* Transformed mycosis fungoides
* Subcutaneous panniculitis-like T-cell lymphoma
* Nasal T/NK-cell lymphoma
* Enteropathy-type T-cell lymphoma
* Hepatosplenic gamma/delta T-cell lymphoma
* Relapsed or refractory disease, meeting both of the following criteria:
* Must have been treated with prior cytotoxic chemotherapy and/or monoclonal antibody therapy
* No standard curative treatment exists
* Allogeneic bone marrow transplantation is not considered standard curative treatment
* Evaluable disease (Phase I)
* Measurable disease, defined as any nodal site or mass lesion ≥ 1.5 cm in longest transverse diameter on physical exam or CT scan OR a measurable extranodal site \> 1 cm (Phase II)
* Patients with evaluable blood- or marrow-based disease are eligible
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³ (Phase I)
* Absolute neutrophil count ≥ 500/mm³ (Phase II)
* Platelet count ≥ 100,000/mm³ (Phase I)
* Platelet count ≥ 50,000/mm³ (Phase II)
* Creatinine \< 2.0 mg/dL\*
* Bilirubin ≤ 2.0 times upper limit of normal (ULN)\*
* AST and ALT ≤ 2.5 times ULN\*
* No active infection requiring antibiotics
* No New York Heart Association class III or IV congestive heart failure
* No known HIV positivity
* No other active malignancy requiring therapy
* No other serious or life-threatening condition deemed unacceptable by the principal investigator
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception NOTE: \*Unless due to lymphoma and patients are entering to the phase II portion of the study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior therapy, including any of the following:
* Interferon
* Antibody therapy
* Retinoids
* Other non-chemotherapeutic treatment
* Concurrent stable-dose corticosteroids allowed
* No colony-stimulating factor therapy during the first course of study therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
120 Years
Study:
NCT00416351
Study Brief:
Protocol Section:
NCT00416351