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

Phase 2

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Other: PET/CT post 2 cycles of chemotherapy

• Registration Number: NCT00392314
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early favorable	PET/CT post 2 cycles of chemotherapy	patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD
Early Unfavorable	PET/CT post 2 cycles of chemotherapy	Patients with early favorable disease Ia or IIa with risk factors :large mediastinal mass extra nodal disease elevated esr, three or more involved areas, age equal or \>50 , lymphocytic depleted or mixed cellularity
advanced disease	PET/CT post 2 cycles of chemotherapy	patients with advanced disease low IPS score 0-2 will start chemotherapy with ABVD for 2 cycles followed by PET/CT further therapy will be given according to PET/CT results
advanced disease IPS 3-7	PET/CT post 2 cycles of chemotherapy	Patients with advanced disease IPS score 3-7 will start chemotherapy with escalated beacopp. following 2 cycles PET/CT will be carried out and according to results further chemotherapy will be given

Primary Outcome Measures

Name	Time	Method
Event Free Survival	5 years
Event Free survival in various risk groups of patients	five years

Secondary Outcome Measures

Name	Time	Method
overall survival5 years	5 years
event free survival 5 years	five years
Disease free survival 5 years	five years

Trial Locations

Locations (1)

RAMBAM health care campus; 🇮🇱 Haifa, Israel