NCT00305149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
Last Updated

March 21, 2006

Status Verified

March 1, 2006

First QC Date

March 20, 2006

Last Update Submit

March 20, 2006

Conditions

Classical Hodgkin LymphomaNodular SclerosisMixed CellularityLymphocyte DepletionLymphocyte Rich

Keywords

Hodgkin LymphomaBEACOPPPETGalliumTailored therapy

Interventions

interim therapy scintigraphy study gallium scan or PET/CTPROCEDURE
"interim gallium or PET/CT"PROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eldad Dann

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ron Epelbaum, ND

    Rambam health care center, Bruce Rappaport Faculty of Medicine Technion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 21, 2006

Study Start

July 1, 1999

Study Completion

December 1, 2005

Last Updated

March 21, 2006

Record last verified: 2006-03

Locations

IL(1)