Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT00305149

Collaborator

(none)

130

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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"	N/A

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jul 1, 1999

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eldad Dann	Haifa		Israel	31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00305149

Other Study ID Numbers:

riskadapted beacopp/CTIL

First Posted:

Mar 21, 2006

Last Update Posted:

Mar 21, 2006

Last Verified:

Mar 1, 2006

Keywords provided by , ,

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Study Results

No Results Posted as of Mar 21, 2006