EUCTR2006-004234-33-IT
Active, not recruiting
Not Applicable
Intensive chemo-immunotherapy as first-line treatment in adult patients with peripheral T-cell Lymphoma PTCL - PTCL intensive chemo-immunotherapy
ISTITUTO NAZIONALE PER LA CURA TUMORI0 sites111 target enrollmentFebruary 19, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- on Hodgkin peripheral T-cell lymphomas
- Sponsor
- ISTITUTO NAZIONALE PER LA CURA TUMORI
- Enrollment
- 111
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 and 60 years for Study A patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures and 60 and 75 years for Study B patients older than 75 years are excluded because of the intensive chemo\-immunotherapy program 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 CD52 expression on neoplastic cells
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Histological PTCL subset other than PTCL\-U, AILD\-T, ALKneg\-ALCL, 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 hypersensivity or anaphylactic reactions to proteins drugs Active secondary malignancy
Outcomes
Primary Outcomes
Not specified
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