Clinical trial · Observational
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
NCT00879528CI-TRIAL-00023518terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure of accrual achievement
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients with negative PET after salvage therapy | Other | — | UNRESOLVED |
| Patients with positive PET after salvage therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
- timeFrame
- 3 years
- measure
- 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
- timeFrame
- 3 years
Secondary outcomes (3)
- measure
- Evaluate the percentage of complete remission.
- timeFrame
- 3 years
- measure
- Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.