Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision. - Full Text View

Sponsors and Collaborators:	Rambam Health Care Campus Hadassah Medical Organization Rabin Medical Center
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00392314

Purpose

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.

Condition	Intervention	Phase
Hodgkin Lymphoma	Procedure: PET/CT	Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

Event Free survival in various risk groups of patients [ Time Frame: five years ] [ Designated as safety issue: No ]
Event Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall survival5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
event free survival 5 years [ Time Frame: five years ] [ Designated as safety issue: No ]
Disease free survival 5 years [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment:	660
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2016
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Intervention Details:

Intrim PET/CT

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

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hodgkin lymphoma patients
age 16-65 for those with early disease and advanced disease with score less then 3
age 16-60 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392314

Contacts

Contact: Eldad J Dann, MD

972-4-8542541

e_dann@rambam.health.gov.il

Locations

Israel
RAMBAM health care campus	Recruiting
Haifa, Israel, 30063
Contact: Eldad J Dann, MD 972-4-8542541 e_dann@rambam.health.gov.il
Contact: Irit Avivi, MD 972-4-8542541 i_avivi@rambam.health.gov.il
Principal Investigator: Eldad J Dann, MD

Sponsors and Collaborators

Rambam Health Care Campus

Hadassah Medical Organization

Rabin Medical Center

Investigators

Study Chair:

Eldad J Dann, MD

RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel

More Information

Responsible Party:	Rambam medical Center Haifa Israel ( Eldad J Dann )
Study ID Numbers:	ISRA2432_CTIL
Study First Received:	October 25, 2006
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00392314
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

hodgkin lymphoma
PET/CT
Therapy

Study placed in the following topic categories:

Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult

Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009