Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305149
Status:
COMPLETED
Last Update Posted:
2006-03-21
First Post:
2006-03-20
Brief Title:
Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 chemotherapyThe 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 beacoppFollowing 2 cycles of therapy the patients were reassessedBased 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 PETCT scan at diagnosis and post first cycle for gallium scan or second cycle for hybrid PETCT 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
Patient with residual uptake interpreted as positive scan had additional cycles of IDB for a total of 6 cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None