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


N/A
18 Years
65 Years
Not Enrolling
Both
Classical Hodgkin Lymphoma, Nodular Sclerosis, Mixed Cellularity, Lymphocyte Depletion, Lymphocyte Rich

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Trial Information

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


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


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:

-

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Principal Investigator

Ron Epelbaum, ND

Investigator Role:

Study Director

Investigator Affiliation:

Rambam health care center, Bruce Rappaport Faculty of Medicine Technion

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

riskadapted beacopp/CTIL

NCT ID:

NCT00305149

Start Date:

July 1999

Completion Date:

December 2005

Related Keywords:

  • Classical Hodgkin Lymphoma
  • Nodular Sclerosis
  • Mixed Cellularity
  • Lymphocyte Depletion
  • Lymphocyte Rich
  • Hodgkin Lymphoma
  • BEACOPP
  • PET
  • Gallium
  • Tailored therapy
  • Hodgkin Disease
  • Lymphoma
  • Sclerosis

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