A Phase 2 interventional study of Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT and Clin B (CHOP- CAMPATH) Chemo-immunotherapy in Lymphoma, T-Cell, Peripheral, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed at 17 sites in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-09-06.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Phase 2, Interventional, and Treatment
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).
Inclusion criteria Clin A
Inclusion criteria Clin B
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.
5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.
This study's enrollment of 92 is above the median of 40 across 4,507 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Clin A: * CHOP-Campath (CHOP-C) for 2 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO on days +1 to +5; Campath-1H (alemtuzumab) dose escalation 3-10-20mg IV days - 2, - 1, 0 (first CHOP-C) or 30mg SC day 0 (second CHOP-C). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on days + 1 and 21 (first and second CHOP-C). * HYPER-C-HiDAM for 2 cycles: Methotrexate 1.5gr/m2 day +1; Cyclophosphamide 300mg/m2 every 12 hours days +2-3-4; ARA-C 2gr/m2 every 12 hours days +2-3-4; G-CSF 5μcg/kg/day starting from day +5 until peripheral blood stem cell harvest * Myeloablative regimen followed by autologous transplantation or Reduced intensity conditioning followed by allogeneic transplantation.
Also known as: Mab - Campath (Alemtuzumab)
Clin B: * CHOP-Campath (CHOP-C) for 6 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO from day +1 to day +5¸ Campath-1H (alemtuzumab) 3-10mg IV on days - 1 and 0 ( first CHOP-C course) or 10mg SC on day 0 (for the following 5 C-CHOP courses). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on day +1 of each CHOP-C course.
Also known as: Mab- Campath (Alemtuzumab)
Efficacy
number of clinical responses
Time frame: one year
evaluation of OS (overall survival)
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.
Time frame: 4 years
DFS (Disease Free Survival)
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)
Time frame: 4 years
TRM (Treatment Related Mortality)
TRM will be analysed by computing the corresponding crude cumulative incidence curve, considering disease-related death as competing event.
Time frame: 4 years
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano