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

Primary Purpose

Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
PET/CT post 2 cycles of chemotherapy
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring hodgkin lymphoma, PET/CT, Therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RAMBAM health care campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Early favorable

Early Unfavorable

advanced disease

advanced disease IPS 3-7

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Event Free survival in various risk groups of patients
Event Free Survival

Secondary Outcome Measures

overall survival5 years
event free survival 5 years
Disease free survival 5 years

Full Information

First Posted
October 25, 2006
Last Updated
May 8, 2014
Sponsor
Rambam Health Care Campus
Collaborators
Hadassah Medical Organization, Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00392314
Brief Title
Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
Collaborators
Hadassah Medical Organization, Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
hodgkin lymphoma, PET/CT, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early favorable
Arm Type
Experimental
Arm Description
patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD
Arm Title
Early Unfavorable
Arm Type
Experimental
Arm Description
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
Arm Title
advanced disease
Arm Type
Experimental
Arm Description
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
Arm Title
advanced disease IPS 3-7
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
PET/CT post 2 cycles of chemotherapy
Other Intervention Name(s)
F18 deoxyglucose scintigraphy
Intervention Description
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
Primary Outcome Measure Information:
Title
Event Free survival in various risk groups of patients
Time Frame
five years
Title
Event Free Survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival5 years
Time Frame
5 years
Title
event free survival 5 years
Time Frame
five years
Title
Disease free survival 5 years
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eldad J Dann, MD
Organizational Affiliation
RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel
Official's Role
Study Chair
Facility Information:
Facility Name
RAMBAM health care campus
City
Haifa
ZIP/Postal Code
30063
Country
Israel

12. IPD Sharing Statement

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

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