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

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ClinicalTrials.gov Identifier: NCT00392314
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : May 9, 2014
Sponsor:
Collaborators:
Hadassah Medical Organization
Rabin Medical Center
Information provided by (Responsible Party):
e_dann, 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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Other: PET/CT post 2 cycles of chemotherapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2006
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: F18 deoxyglucose scintigraphy




Primary Outcome Measures :
  1. Event Free survival in various risk groups of patients [ Time Frame: five years ]
  2. Event Free Survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. overall survival5 years [ Time Frame: 5 years ]
  2. event free survival 5 years [ Time Frame: five years ]
  3. Disease free survival 5 years [ Time Frame: five years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392314


Locations
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Israel
RAMBAM health care campus
Haifa, Israel, 30063
Sponsors and Collaborators
Rambam Health Care Campus
Hadassah Medical Organization
Rabin Medical Center
Investigators
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Study Chair: Eldad J Dann, MD RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel

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Responsible Party: e_dann, Eldad J Dann assoc Prof of Hematology (Clinical), director of blood bank and aphaeresis unit RAMBAM health care campus Haifa Israel, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00392314     History of Changes
Other Study ID Numbers: ISRA2432_CTIL
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by e_dann, Rambam Health Care Campus:
hodgkin lymphoma
PET/CT
Therapy

Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents