Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma

March 20, 2006 updated by: Rambam Health Care Campus

Use of Risk Factors for Initiation Therapy With Beacopp or Escalated Beacopp and Interim Evaluation and Modification of Therapy Based on Scintigraphy Results.

.This study is trying to address change of chemotherapy dosage according to individual patient response to initial cycles of chemotherapy in order to reduce cumulative dose of chemotherapy.The study includes patients with early unfavorable and advanced hodgkin lymphoma. Patients with low risk were started with standard beacopp and only high risk patients were started with escalated beacopp.Following 2 cycles of therapy the patients were reassessed.Based on scintigraphy results decision was made regarding further therapylative chemotherapy for early responders and maximize dose intensity for late responders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were eligible if they had early unfavorable disease or patients who presented with stage III or IV disease .Pt assigned to receive 6 cycles of Bleomycin Etoposide, Doxorubicin, Cyclophosphamide Procarbazine, Prednisone (BEACOPP) or increased dose BEACOPP. (IDB). Patient with Stage I or II with ³4 sites of disease, age ³50, ESR³50 "B" symptoms lymphocyte depleted histology "E" site, or bulky disease were defined as early unfavorable disease and were given standard BEACOPP (SB). Those with I, II B or bulky disease or Stage III, IV were defined according the IPS. Increased dose BEACOPP (IDB) cycles of therapy was initiated only to patients with IPS of 3 or more risk factors (high risk) Standard BEACOPP (SB) cycles were initiated to those with a score of 0-2 (standard risk). All patients had baseline GA67 or hybrid PET\CT scan at diagnosis and post first cycle for gallium scan or second cycle for hybrid PET\CT. Upon the scan results therapy was planned and given for addition of 4 cycles. Those with negative scan received cycles of SB as of the third cycle. Dose was reduced to level I to III if patient was hospitalized due to fever and neutropenia of 5 days or longer or pt had an episode of sepsis with unstable vital signs.

Patient with residual uptake interpreted as positive scan had additional cycles of IDB for a total of 6 cycles

Study Type

Interventional

Enrollment

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Eldad Dann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stage I-IIA/B with adverse prognostic or III-IV disease
  • Age 18 and Over
  • Performance status ECOG 0-3
  • Hematopoietic WBC at least 4000/mm3(unless documented bone marrow involvement)
  • Hepatic bilirubin no greater then 5 mg/dL
  • RENAL:Creatinine no greater than 2.0mg/dL
  • not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No other malignancy within the past 5 years

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Study Director: Ron Epelbaum, ND, Rambam health care center, Bruce Rappaport Faculty of Medicine Technion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 21, 2006

Study Record Updates

Last Update Posted (Estimate)

March 21, 2006

Last Update Submitted That Met QC Criteria

March 20, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • riskadapted beacopp/CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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