Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma (PTCL-06)
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|ClinicalTrials.gov Identifier: NCT01679860|
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related toxicity and mortality. The investigators have recently proved feasibility and potential efficacy of a RIC regimen in relapsed PTCL patients.
We want to investigate whether it is possible to improve the outcome of alk negative PTCL pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.
The intensification will be obtained by combining intensive chemotherapy, alemtuzumab (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between 61 and 70 years(Clinical Study B).
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, T-Cell, Peripheral||Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||August 2012|
Experimental: Clin A
Clin A. CHOP-Campath (CHOP-C) for 2 cycles , Hyper-C-Hidam for 2 cycles and auto-SCT (stem cell transplantation) or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and ≤ 60 years
Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT
Other Name: Mab - Campath (Alemtuzumab)
Experimental: Clin B
Clin B: CHOP-Campath (CHOP-C) for 6 cycles . It is a combined immunochemotherapy approach in a subset of elderly pts aged > 60 ≤ 75 years
Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy
Other Name: Mab- Campath (Alemtuzumab)
- Efficacy [ Time Frame: one year ]number of clinical responses
- evaluation of OS (overall survival) [ Time Frame: 4 years ]OS time is calculated from patients enrollment to death for all causes; censored cases are pts alive at the date of last follow-up assessment.
- DFS (Disease Free Survival) [ Time Frame: 4 years ]DFS time is the interval between CR achievement and the first disease relapse or death regardless of the cause.Definition of disease response/progression will be performed according to the criteria published by Juweid et al.(J Clin Oncol. 2005; 23: 4652-61)
- TRM (Treatment Related Mortality) [ Time Frame: 4 years ]TRM will be analysed by computing the corresponding crude cumulative incidence curve, considering disease-related death as competing event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679860
|Principal Investigator:||paolo corradini||fondazione IRCCS istituto nazionale tumori Milano|