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Clinical Trials/ACTRN12612000137897
ACTRN12612000137897
Not yet recruiting
Phase 2

A Phase II Single Arm Study Assessing The Feasibility And Toxicity Of Dose-Dense ABVD In Patients With Early Stage Unfavourable And Advanced Stage Hodgkin Lymphoma.

Queensland Health0 sites31 target enrollmentFebruary 1, 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Early Stage Unfavourable Hodgkin Lymphoma
Sponsor
Queensland Health
Enrollment
31
Status
Not yet recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 1, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Confirmed histological diagnosis of Hodgkin Lymphoma
  • Staging consistent with either early stage unfavourable or advanced stage disease according to the GHSG staging system
  • ECOG performance status 0 to 2 inclusive
  • No prior therapy for Hodgkin Lymphoma except for a short course of steroids for initial symptom control
  • Written informed consent prior to study registration
  • Patients of child bearing potential must use adequate contraception

Exclusion Criteria

  • Prior or current disease which prevents treatment with protocol chemotherapy
  • Abnormal laboratory parameters (unless due to disease)
  • Concurrent or previous malignancy except adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix or other solid tumours treated for cure with no evidence of disease for more than or equal to 2 years
  • Presence of positive test results in human immunodeficiency virus (HIV), Hepatitis B (HB surface antigen \[HBsAg], total HB core antibody \[anti\-HB\-c]) and Hepatitis C (Hepatitis C virus \[HCV] antibody) serology testing.
  • Likely inability of the patient to comply with treatment assessments
  • Pregnancy and lactation. Adults of reproductive potential must agree to use an effective method of birth control during treatment and for at least 3 months thereafter
  • Prior solid organ transplantation

Outcomes

Primary Outcomes

Not specified

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