Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00305149
First received: March 20, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted

March 20, 2006
March 20, 2006
July 1999
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No Changes Posted
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Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma
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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Classical Hodgkin Lymphoma
  • Nodular Sclerosis
  • Mixed Cellularity
  • Lymphocyte Depletion
  • Lymphocyte Rich
  • Procedure: interim therapy scintigraphy study gallium scan or PET/CT
  • Procedure: "interim gallium or PET/CT"
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2005
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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:

-

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00305149
riskadapted beacopp/CTIL
Not Provided
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Rambam Health Care Campus
Not Provided
Study Director: Ron Epelbaum, ND Rambam health care center, Bruce Rappaport Faculty of Medicine Technion
Rambam Health Care Campus
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP