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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00392314
Other study ID # ISRA2432_CTIL
Secondary ID
Status Completed
Phase Phase 2
First received October 25, 2006
Last updated May 8, 2014
Start date October 2006
Est. completion date May 2014

Study information

Verified date May 2014
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 365
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel RAMBAM health care campus Haifa

Sponsors (3)

Lead Sponsor Collaborator
Rambam Health Care Campus Hadassah Medical Organization, Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event Free survival in various risk groups of patients five years No
Primary Event Free Survival 5 years No
Secondary overall survival5 years 5 years No
Secondary event free survival 5 years five years No
Secondary Disease free survival 5 years five years No
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