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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Istituto Clinico Humanitas
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00879528
First received: April 9, 2009
Last updated: September 14, 2015
Last verified: September 2015
  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: September 2015
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
Rozzano, Milano, Italy
AUSL di Ravenna
Ravenna, RA, Italy, 48100
A.O. Bianchi - Melacrino - Morelli
Reggio Calabria, RC, Italy, 89125
Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo
Candiolo, Torino, Italy, 10060
A.O. S. Maria di Terni
Terni, TR, Italy, 05100
S.C. Oncologia Medica III Osp. di Circolo
Busto Arsizio, Varese, Italy, 21052
A.O.SS. Biagio, Antonio e Cesare Arrigo
Alessandria, Italy
AORN San G.Moscati
Avellino, Italy
Centro di riferimento Oncologico - Oncologia Medica A
Aviano (PN), Italy
Azienda Ospedaliera Policlinico di Bari
Bari, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Italy, 40138
Spedali Civili
Brescia, Italy
Presidio Ospedaliero A.Perrino - Divisione di Ematologia
Brindisi, Italy
Ospedale A.Businco
Cagliari, Italy
AO Santa Croce e Carle
Cuneo, Italy, 12100
A.O. Universitaria Careggi Di Firenze
Firenze, Italy, 50139
Area Vasta Romagna e IRST
Meldola (FC), Italy
Azienda Ospedaliera Papardo
Messina, Italy
Ospedale Niguarda Cà Granda
Milano, Italy
San Raffaele
Milano, Italy
Centro Oncologico Modenese
Modena, Italy
AOU Federico II di Napoli
Napoli, Italy
AOU Maggiore della Carità
Novara, Italy
ASL 3 Nuoro, UOC Ematologia e CTMO HSF
Nuoro, Italy, 08100
Ematologia Policlinico San Matteo
Pavia, Italy, 27100
Ospedale Civile G.da Saliceto - UOA Ematologia
Piacenza, Italy
Ospedale degli Infermi - Ematologia
Rimini, Italy
Itituto Regina Elena IFO
Roma, Italy
Ospedale S.Eugenio
Roma, Italy
Univeristà La Sapienza
Roma, Italy
Università Cattolica Policlinico Gemelli - Cattedra di Ematologia
Roma, Italy
Casa sollievo della sofferenza
San Giovanni Rotondo, Italy
AO Universitaria senese
Siena, Italy
Azienda Ospedaliera di Terni
Terni, Italy
Ospedale San Giovanni Battista - Molinette
Torino, Italy
ASL BAT 1 Divsione di Ematologia
Trani, Italy
A.O.Cardinale Panico Ematologia e centro trapianti
Tricase (LE), Italy
AO Universitaria di Udine
Udine, Italy
Oncologia Medica Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania
Verbania, Italy, 28900
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Istituto Clinico Humanitas
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

Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT00879528     History of Changes
Other Study ID Numbers: IIL-HD0802 
Study First Received: April 9, 2009
Last Updated: September 14, 2015
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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2016