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

May 8, 2014 updated by: e_dann, Rambam Health Care Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 30063
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early favorable
patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD
Other: PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Other Names:
  • F18 deoxyglucose scintigraphy
Experimental: Early Unfavorable
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
Other: PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Other Names:
  • F18 deoxyglucose scintigraphy
Experimental: advanced disease
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
Other: PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Other Names:
  • F18 deoxyglucose scintigraphy
Experimental: advanced disease IPS 3-7
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
Other: PET/CT post 2 cycles of chemotherapy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Other Names:
  • F18 deoxyglucose scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event Free survival in various risk groups of patients
Time Frame: five years
five years
Event Free Survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival5 years
Time Frame: 5 years
5 years
event free survival 5 years
Time Frame: five years
five years
Disease free survival 5 years
Time Frame: five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISRA2432_CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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