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

This study has been terminated.
(Failure of accrual achievement)
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: August 16, 2016
Last verified: August 2016

April 9, 2009
August 16, 2016
May 2009
May 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00879528 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory
Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse
Hodgkin's Lymphoma
  • 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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
264
September 2015
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00879528
IIL-HD0802
No
Not Provided
Not Provided
Fondazione Italiana Linfomi ONLUS
Fondazione Italiana Linfomi ONLUS
Istituto Clinico Humanitas
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
Fondazione Italiana Linfomi ONLUS
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP