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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00879528
First received: April 9, 2009
Last updated: June 23, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention
Hodgkin's Lymphoma
Other: Patients with negative PET after salvage therapy
Other: Patients with positive PET after salvage therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Linfomi ONLUS:

Primary Outcome Measures:
  • Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the percentage of complete remission. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluation of the chimera. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879528

Contacts
Contact: Antonella Ferranti 0131/206129 aferranti@ospedale.al.it
Contact: Daniela Gioia 0131/206129 dgioia@ospedale.al.it

Locations
Italy
A.O.SS. Biagio, Antonio e Cesare Arrigo Recruiting
Alessandria, Italy
Principal Investigator: Alessandro Levis, MD         
AORN San G.Moscati Recruiting
Avellino, Italy
Principal Investigator: Nicola Cantore, MD         
Centro di riferimento Oncologico - Oncologia Medica A Not yet recruiting
Aviano (PN), Italy
Principal Investigator: Michele Spina, MD         
Azienda Ospedaliera Policlinico di Bari Not yet recruiting
Bari, Italy
Principal Investigator: Giorgina Specchia, MD         
Spedali Civili Recruiting
Brescia, Italy
Principal Investigator: Giuseppe Rossi, MD         
Presidio Ospedaliero A.Perrino - Divisione di Ematologia Active, not recruiting
Brindisi, Italy
Ospedale A.Businco Not yet recruiting
Cagliari, Italy
Principal Investigator: Emanuele Angelucci, MD         
Azienda Ospedaliera Papardo Recruiting
Messina, Italy
Principal Investigator: Maura Brugiatelli, MD         
San Raffaele Not yet recruiting
Milano, Italy
Principal Investigator: Andres Ferreri, MD         
Ospedale Niguarda Cà Granda Recruiting
Milano, Italy
Principal Investigator: Livio Gargantini         
Centro Oncologico Modenese Not yet recruiting
Modena, Italy
Principal Investigator: Massimo Federico, PhD         
AOU Federico II di Napoli Recruiting
Napoli, Italy
Principal Investigator: Marco Picardi, MD         
AOU Maggiore della Carità Recruiting
Novara, Italy
Principal Investigator: Gianluca Gaidano, PhD         
Ospedale La Maddalena Not yet recruiting
Palermo, Italy
Principal Investigator: Maurizio Musso, MD         
Ospedale Civile G.da Saliceto - UOA Ematologia Active, not recruiting
Piacenza, Italy
Ospedale degli Infermi - Ematologia Recruiting
Rimini, Italy
Principal Investigator: Pierpaolo Fattori, MD         
Ospedale S.Eugenio Not yet recruiting
Roma, Italy
Principal Investigator: Elisabetta Abruzzese, MD         
Univeristà La Sapienza Not yet recruiting
Roma, Italy
Principal Investigator: Alessandro Pulsoni, MD         
Università Cattolica Policlinico Gemelli - Cattedra di Ematologia Not yet recruiting
Roma, Italy
Principal Investigator: Stefan Hohaus, Md         
Itituto Regina Elena IFO Not yet recruiting
Roma, Italy
Principal Investigator: Maria Concetta Petti, MD         
Casa sollievo della sofferenza Not yet recruiting
San Giovanni Rotondo, Italy
Principal Investigator: Nicola Cascavilla, MD         
AO Universitaria senese Recruiting
Siena, Italy
Principal Investigator: Alberto Fabbri, MD         
Azienda Ospedaliera di Terni Not yet recruiting
Terni, Italy
Principal Investigator: Anna Marina Liberati, MD         
Ospedale San Giovanni Battista - Molinette Recruiting
Torino, Italy
Principal Investigator: Umberto Vitolo, MD         
AO Universitaria di Udine Not yet recruiting
Udine, Italy
Principal Investigator: Francesco Zaja, MD         
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
Study Director: Luca Castagna, MD Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
Study Director: Armando Santoro, MD Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
  More Information

No publications provided

Responsible Party: Prof. Armando Santoro, Istituto clinico Humanitas - Dipartimento di Oncologia ed Ematologia
ClinicalTrials.gov Identifier: NCT00879528     History of Changes
Other Study ID Numbers: IIL-HD0802
Study First Received: April 9, 2009
Last Updated: June 23, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Linfomi ONLUS:
Hodgkin's Lymphoma
stem cell reinfusion

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014