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CompletedNCT00305149Updated Mar 21, 2006

Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma

An interventional study of interim therapy scintigraphy study gallium scan or PET/CT and "interim gallium or PET/CT" in Classical Hodgkin Lymphoma, Nodular Sclerosis and Mixed Cellularity, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-03-21.

Sponsored by Rambam Health Care Campus · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

.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.

Read the 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

02

Conditions studied

  • Classical Hodgkin Lymphoma
  • Nodular Sclerosis
  • Mixed Cellularity
  • Lymphocyte Depletion
  • Lymphocyte Rich

Keywords

  • Hodgkin Lymphoma
  • BEACOPP
  • PET
  • Gallium
  • Tailored therapy
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 130 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants

Interventions

  • Procedureinterim therapy scintigraphy study gallium scan or PET/CT
  • Procedure"interim gallium or PET/CT"
06

Study locations

1 site
  • Eldad Dann
    Haifa, 31096, Israel
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00305149
Lead sponsor
Rambam Health Care Campus
First posted
Mar 21, 2006
Start date
Jul 1999
Completion
Dec 2005
Last update
Mar 21, 2006

Study contacts

Ron Epelbaum, ND
study director · Rambam health care center, Bruce Rappaport Faculty of Medicine Technion
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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