Clinical trial NCT00392314: Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: hodgkin lymphoma
PET/CT
Therapy
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Hadassah Medical Organization
name: Rabin Medical Center
First posted: 2006-10-26
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Hodgkin lymphoma patients
* age 18-60 for those with early disease and advanced disease with score less then 3
* age 18-60 years for patients with advanced disease score 3 or higher classical Hodgkin lymphoma
* WBC more then 3500
* platelets more then 100000
* creatinin less then 2.0 mg
* bilirubin less then 2.0 mg
* absolute neutrophil count more then 1000 unless bone marrow involvement If marrow involve, patient with lower count but ANC of 1000 may be included.

Exclusion Criteria:

* Positive serology for HIV
* bilirubin more then 2 mg/dl
* creatinin more then 2 mg/dl
* lactating woman or pregnant
* patient older then 60 years with high risk disease of score 3 or more

Primary outcomes:
measure: Event Free survival in various risk groups of patients
timeFrame: five years
measure: Event Free Survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival5 years
timeFrame: 5 years
measure: event free survival 5 years
timeFrame: five years
measure: Disease free survival 5 years
timeFrame: five years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM health care campus
Study officials:
affiliation: RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel
name: Eldad J Dann, MD
role: STUDY_CHAIR
References: