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

NCT00392314 | Completed Phase 2

• 1 other identifier: ISRA2432_CTIL
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Keywords

hodgkin lymphoma; PET/CT; Therapy

Outcome Measures

Primary Outcomes (2)

• Event Free survival in various risk groups of patients

  five years

• Event Free Survival

  5 years

Secondary Outcomes (3)

• overall survival5 years

  5 years

• event free survival 5 years

  five years

• Disease free survival 5 years

  five years

Study Arms (4)

Early favorable

EXPERIMENTAL

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

Early Unfavorable

EXPERIMENTAL

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

advanced disease

EXPERIMENTAL

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

advanced disease IPS 3-7

EXPERIMENTAL

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

Interventions

PET/CT post 2 cycles of chemotherapy OTHER

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

Also known as: F18 deoxyglucose scintigraphy

Early Unfavorable; Early favorable; advanced disease; advanced disease IPS 3-7

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Hadassah Medical Organization: collaborator
• Rabin Medical Center: collaborator

Study Sites (1)

RAMBAM health care campus

Haifa, 30063, Israel

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Eldad J Dann, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eldad J Dann assoc Prof of Hematology (Clinical), director of blood bank and aphaeresis unit RAMBAM health care campus Haifa Israel

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

IL (1)