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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT01679860
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 \<60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
* Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL
* Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
* Written informed consent
Exclusion Criteria:
* Histological PTCL subset other than PTCL-U, AILD-T ALCL-ALKneg, intestinal T - NHL
* Central nervous system localization
* Positive serologic markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection
* Serum bilirubin levels \> 2 the upper normal limit
* Clearance of creatinine \< 50 ml/min
* DLCO \< 50%
* Ejection fraction \< 45% (or myocardial infarction in the last 12 months)
* Pregnancy or lactation
* Patient not agreeing to take adequate contraceptive measures during the study
* Psychiatric disease
* Any active, uncontrolled infection
* Type I hypersensitivity or anaphylactic reactions to proteins drugs
* Active secondary malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01679860
Study Brief:
Protocol Section:
NCT01679860