Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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) |
-
Other: Patients with negative PET after salvage therapy
- 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.
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:
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 |
Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse
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| Contact: Antonella Ferranti | 0131/206129 | aferranti@ospedale.al.it |
| Contact: Daniela Gioia | 0131/206129 | dgioia@ospedale.al.it |
| 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 | |
| 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 May 19, 2013