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

Hodgkin Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392314
• Other study ID #: ISRA2432_CTIL
• 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

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

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