Hodgkin Lymphoma Clinical Trial
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.
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.
Status | Completed |
Enrollment | 365 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | RAMBAM health care campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Hadassah Medical Organization, Rabin Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event Free survival in various risk groups of patients | five years | No | |
Primary | Event Free Survival | 5 years | No | |
Secondary | overall survival5 years | 5 years | No | |
Secondary | event free survival 5 years | five years | No | |
Secondary | Disease free survival 5 years | five years | No |
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