Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

December 31, 2011

Study Completion Date

August 31, 2012

Conditions
Lymphoma, T-Cell, Peripheral
Interventions
PROCEDURE

Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT

"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."

DRUG

Clin B (CHOP- CAMPATH) Chemo-immunotherapy

"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."

Trial Locations (17)

10043

Azienda Ospedaliera S. Luigi, Orbassano

10126

Azienda OspedalieraSan Giovanni Battista, Torino

Università di Torino- Azienda Ospedaliera S. Giovanni Battista, Torino

12100

Ospedale S. Croce - Division of Hematology, Cuneo

15100

Ospedale SS. Antonio e Biagio e Cesare Arrigo, Alessandria

20100

Ospedale San Raffaele, Milano - Division of Hematology, Milan

20122

IRCCS Ospedale Maggiore Policlinico di Milano, Milan

20133

Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori, Milan

24128

Ospedale Riuniti, Bergamo - Division of Hematology, Bergamo

25123

Spedali Civili di Brescia, Brescia

37134

Azienda Ospedaliera Policlinico di Verona, Verona

39100

Ospedale Generale Regionale Bolzano, Bolzano

62020

University of Ancona - Division of Hematology, Ancona

85100

Ospedale San Carlo, Potenza

94124

Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania, Catania

Unknown

Policlinico Universitario Udine, Udine

Ospedale Cervello - Bone Marrow Transplantation Unit, Palermo

All Listed Sponsors
lead

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

NCT01679860 - Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma | Biotech Hunter | Biotech Hunter