NCT00392314

Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.

Phase 2 Study.Tailored Therapy for Hodgkin Lymphoma Based on Predefined Risk Factors and Early Interim PET/CT for Response Assessment and Further Therapy Decisions.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Recently published studies demonstrated very high event free survival for patients with a normal interim PET/CT and a high hazard ratio for progression of an interim positive (pathological)study. These findings strongly support the integration of interim PET as a decision point for adjustment of chemotherapy.This study use the minimal therapy considered safe according to the predefined risk factors for patients with interim negative PET. Those with pathologic interim study considered as higher risk patients will have dose escalation of therapy.remission rate ,event free survival and overall survival will be evaluated.

Detailed description

study aim is to tailor the therapy in order to administer the lowest cumulative dose of therapy yet considered safe in order to reduce both early and late therapy related complications. patients will be divided according to risk factors to sub groups of early favorable, early unfavorable, advanced disease with score less then 3 points or higher then 3 points. Early Interim PET will be carried out Further therapy will be based on the study results.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
OTHER	PET/CT post 2 cycles of chemotherapy	sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy

Timeline

• Start date: 2006-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2006-10-26
• Last updated: 2014-05-09

Locations

1 site across 1 country: Israel