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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00453427
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years of age or older at time of enrollment,
* Histologically proven and centrally reviewed CD52+ T-cell NHL Stages 2-4 including the following nodal and extranodal subtypes:
Nodal:
* Peripheral T-cell lymphoma not otherwise specified (PTL NOS)
* Angioimmunoblastic lymphadenopathy (AILD)
* ALK 1 negative anaplastic large cell NHL
Extranodal:
* Hepatosplenic
* Enteropathy-associated
* Panniculitic
Exclusion Criteria:
* Previous treatment with chemotherapy or radiation with the exception of up to 1 cycle of CHOP chemotherapy.
* Expected survival \< 4 months.
* ECOG performance status \> 3.
* Inadequate haematologic function (Hb \< 85g/L, ANC \< 1000/mm3, or platelet count \< 75,000/mm3) unless directly attributable to the NHL.
* Inadequate hepatic function (total bilirubin \> 35μmol/L, alkaline phosphatase \> 2x UL normal, AST/ALT \> 2x UL normal)
* Inadequate renal function (serum creatinine \> 130μmol/L), unless directly attributable to the NHL.
* Non-measurable or non-evaluable disease, according to criteria of Cheson et al49.
* Geographically inaccessible for follow-up
* Known hypersensitivity to study drugs
* Serious illnesses that may interfere with subject compliance, determination of causality of adverse events or would compromise other protocol objectives.
* Known HIV positivity or other pre-existing immunodeficiency (e.g., post-organ transplant).
* Known CNS involvement with lymphoma (tests to investigate CNS involvement are required only if clinically indicated).
* Pregnant or lactating women.
* Women who are of childbearing potential but are not using effective contraception. Men with reproductive potential who are not using effective contraception.
* Previous malignancy within the last 5 years with the exception of cervical carcinoma in situ or non melanoma skin cancer.
* Nasal natural killer (NK) T-cell NHL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00453427
Study Brief:
Protocol Section:
NCT00453427