PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy.
This is a prospective observational study in which patients with positive PET scan after salvage therapy are candidates to a sequential scheme "auto-allotransplantation" in case of availability of a donor . In the event of unavailability of a donor , the same patients are candidates for a double high-dose chemotherapy with autologous stem cell support.
Study Type
OBSERVATIONAL
Enrollment
264
All patients included in the study will treat with a salvage scheme according to each center. After the end of salvage therapy, consolidation depends on the outcome of PET: PET negative: These patients will follow a standard treatment that includes high-dose chemotherapy with reinfusion of autologous peripheral stem cells.
All patients included in the study will treat with a salvage scheme according to each center. After the end of salvage therapy, consolidation depends on the outcome of PET PET positive, the consolidation therapy consists of 2 phases: * phase1:common to all consists in a series of high-dose chemotherapy with Melphalan 200 mg/sqm, followed by reinfusion of autologous peripheral stem cells * phase2:depends on the availability of a compatible donor. If there is a donor, the patient will continue with an allogeneic transplant preceded by a reduced intensity conditioning. If there is not a donor, the patient will continue with a second round of high-dose chemotherapy with BEAM with reinfusion of autologous peripheral stem cells.
Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
Time frame: 3 years
Patients with positive PET after salvage therapy. Evaluate the role of allogeneic transplantation in these patients after salvage chemotherapy and compare the results with those obtained by 2 cycles of high dose chemotherapy with stem cell
Time frame: 3 years
Evaluate the percentage of complete remission.
Time frame: 3 years
Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
Time frame: 3 years
Evaluation of the chimera.
Time frame: 3 years
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Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola
Bologna, Bologna, Italy
Unità funzionale di Ematologia AOU Careggi
Florence, Firenze, Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
Rozzano, Milano, Italy
Ematologia Policlinico San Matteo
Pavia, Pavia, Italy
Ematologia Ospedale S. Maria delle Croci
Ravenna, RA, Italy
Div Ematologia A.O. Bianchi - Melacrino - Morelli
Reggio Calabria, RC, Italy
Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Torino, Italy
S.C. Oncologia Medica III Osp. di Circolo
Busto Arsizio, Varese, Italy
UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania
Verbania, Verbania, Italy
SC Ematologia - A.O.SS. Biagio, Antonio e Cesare Arrigo
Alessandria, Italy
...and 29 more locations