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

NCT ID: NCT00392314

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early favorable

patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD

Group Type EXPERIMENTAL

PET/CT post 2 cycles of chemotherapy

Intervention Type OTHER

sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy

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

Group Type EXPERIMENTAL

PET/CT post 2 cycles of chemotherapy

Intervention Type OTHER

sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy

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

Group Type EXPERIMENTAL

PET/CT post 2 cycles of chemotherapy

Intervention Type OTHER

sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy

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

Group Type EXPERIMENTAL

PET/CT post 2 cycles of chemotherapy

Intervention Type OTHER

sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy

Interventions

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PET/CT post 2 cycles of chemotherapy

sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy

Intervention Type OTHER

Other Intervention Names

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F18 deoxyglucose scintigraphy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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e_dann

Eldad J Dann assoc Prof of Hematology (Clinical), director of blood bank and aphaeresis unit RAMBAM health care campus Haifa Israel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eldad J Dann, MD

Role: STUDY_CHAIR

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

Locations

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RAMBAM health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ISRA2432_CTIL

Identifier Type: -

Identifier Source: org_study_id

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