Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory

NCT ID: NCT00879528

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 264 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Hodgkin's Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Patients with negative PET after salvage therapy

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.

Intervention Type: OTHER

Patients with positive PET after salvage therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients confirmed Hodgkin's lymphoma at refractory at first line therapy, relapse early or late;
• Age > 18 years;
• Life expectancy > 3 months;
• Cardiac, pulmonary, renal and liver functions with normal range;
• Written informed consent.

Exclusion Criteria

• Any psychological, familiar or geographical conditions that could potentially hinder the compliance to the protocol;
• renal failure as creatinine> 1.2 mg/dl or creatinine clearance <60 ml/min;
• AST/ALT or bilirubin> 2.5 times the norm;
• HCV positivity with signs of ongoing viral replication (HCV PCR + AST>1.5-2x normal);
• Heart disease clinically significant: eg. severe hypertension not controlled, multifocal uncontrolled cardiac arrhythmias, symptomatic ischemic heart disease or congestive heart failure class NYHA class III-IV (Annex 2), previous acute myocardial infarction;
• Ventricular ejection fraction <45%;
• decompensated diabetes mellitus not controlled by insulin therapy; Disease with significant pulmonary function defined as FEV1 <65% of predicted or DLCO <50% of predicted value;
• HIV positive patients;
• Patients with uncontrolled infection;
• Neoplasia in the last 3 years except carcinoma in situ uterus, neck and basal skin cancer or prostate cancer in early stage localized exeresi treated with surgery or brachytherapy with curative intent, a good prognosis DCIS breast treated with surgery alone;
• Drug addiction or alcoholism.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: collaborator

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Castagna, MD

Role: STUDY_DIRECTOR

Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia

Armando Santoro, MD

Role: STUDY_DIRECTOR

Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia

Locations

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

SC Enatologia e Trapianto emopoietico AORN San G.Moscati

Avellino, , Italy

Centro di Riferimento Oncologico - Oncologia Medica A

Aviano (PN), , Italy

Azienda Ospedaliera Policlinico di Bari

Bari, , Italy

Ematologia Spedali Civili

Brescia, , Italy

Presidio Ospedaliero A.Perrino - Divisione di Ematologia

Brindisi, , Italy

Ematologia Ospedale A.Businco

Cagliari, , Italy

SC Ematologia ASO S. Croce e Carle

Cuneo, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola (FC), , Italy

SC Ematologia Azienda Ospedaliera Papardo Nesima

Messina, , Italy

Ematologia Ospedale Niguarda Cà Granda

Milan, , Italy

Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele

Milan, , Italy

Centro Oncologico Modenese

Modena, , Italy

AOU Federico II di Napoli

Napoli, , Italy

SCDU Ematologia AOU Maggiore della Carità

Novara, , Italy

ASL 3 Nuoro, UOC Ematologia e CTMO HSF

Nuoro, , Italy

UO Ematologia Ospedale Civile G.da Saliceto

Piacenza, , Italy

Ospedale degli Infermi - Ematologia

Rimini, , Italy

Istituto Regina Elena IFO

Roma, , Italy

Univeristà La Sapienza

Roma, , Italy

Università Cattolica Policlinico Gemelli - Cattedra di Ematologia

Roma, , Italy

UOC Ematologia Ospedale S.Eugenio

Roma, , Italy

Casa sollievo della Sofferenza

San Giovanni Rotondo, , Italy

UOC Ematologia e Trapianti AO Universitaria senese

Siena, , Italy

SC Oncoematologia Azienda Ospedaliera S. Maria di Terni

Terni, , Italy

SC Ematologia Ospedale San Giovanni Battista - Molinette

Torino, , Italy

ASL BAT 1 Divisione di Ematologia

Trani, , Italy

A.O.Cardinale Panico Ematologia e centro trapianti

Tricase (LE), , Italy

Clinica Ematologica ASUI Integrata di Udine

Udine, , Italy

Oncologia Medica Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Countries

Italy

Other Identifiers

IIL-HD0802

Identifier Type: -

Identifier Source: org_study_id