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Completed

NCT Number: NCT00392314

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RAMBAM health care campus

Haifa, 30063, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT post 2 cycles of chemotherapy

Other

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

Other names: F18 deoxyglucose scintigraphy

Primary outcomes

  1. Event Free survival in various risk groups of patients

    Time frame: five years

  2. Event Free Survival

    Time frame: 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Hadassah Medical Organization
  • Rabin Medical Center

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Oct 26, 2006
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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