Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma

NCT ID: NCT00305149

Last Updated: 2006-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-07-31
• Study Completion Date: 2005-12-31

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.

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

interim therapy scintigraphy study gallium scan or PET/CT

Intervention Type: PROCEDURE

"interim gallium or PET/CT"

Intervention Type: PROCEDURE

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Principal Investigators

Ron Epelbaum, ND

Role: STUDY_DIRECTOR

Rambam health care center, Bruce Rappaport Faculty of Medicine Technion

Locations

Eldad Dann

Haifa, , Israel

Countries

Israel

Other Identifiers

riskadapted beacopp/CTIL

Identifier Type: -

Identifier Source: org_study_id