Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)
18 Years
60 Years
Both
Lymphoma, T-Cell, Peripheral
Trial Information
Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)
Inclusion criteria Clin A
- Age ≥18 < or =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
Inclusion criteria Clin B
- Age >60 and ≤75 years (patients older than 75 years are excluded because of the
intensive chemo-immunotherapy program)
- Histological 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
- Informed written consent
In clinical study A (Clin A) we are planning to evaluate the efficacy and the feasibility of
an intensified chemo-immunotherapy program including auto-SCT or RIC allo-SCT in advanced
stage PTCL pts ≥ 18 and < or = 60 years.
In clinical study B (Clin B) we intend to verify the efficacy and the feasibility of a
combined immuno-chemotherapy approach in a subset of elderly pts aged > 60 and < or = 75
years.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Outcome Description:
number of clinical responses
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
paolo corradini
Investigator Role:
Principal Investigator
Investigator Affiliation:
fondazione IRCCS istituto nazionale tumori Milano
Authority:
Italy: The Italian Medicines Agency
Study ID:
PTCL-062006-004234-33
NCT ID:
NCT01679860
Start Date:
November 2006
Completion Date:
August 2012
Related Keywords:
- Lymphoma, T-Cell, Peripheral
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
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