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

Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00879528
• Other study ID #: IIL-HD0802
• Status: Terminated
• Phase: N/A
• First received: April 9, 2009
• Last updated: August 16, 2016
• Start date: May 2009
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 264
• Est. completion date: September 2015
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
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	Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola	Bologna
Italy	Ematologia Spedali Civili	Brescia
Italy	Presidio Ospedaliero A.Perrino - Divisione di Ematologia	Brindisi
Italy	S.C. Oncologia Medica III Osp. di Circolo	Busto Arsizio	Varese
Italy	Ematologia Ospedale A.Businco	Cagliari
Italy	Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS	Candiolo	Torino
Italy	SC Ematologia ASO S. Croce e Carle	Cuneo
Italy	Unità funzionale di Ematologia AOU Careggi	Firenze
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	Milano
Italy	Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele	Milano
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	Ematologia Policlinico San Matteo	Pavia
Italy	UO Ematologia Ospedale Civile G.da Saliceto	Piacenza
Italy	Ematologia Ospedale S. Maria delle Croci	Ravenna	RA
Italy	Div Ematologia A.O. Bianchi - Melacrino - Morelli	Reggio Calabria	RC
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	Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas	Rozzano	Milano
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	UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania	Verbania

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS	Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free		3 years	No
Primary	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		3 years	No
Secondary	Evaluate the percentage of complete remission.		3 years	No
Secondary	Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).		3 years	No
Secondary	Evaluation of the chimera.		3 years	No