Dose-Dense ABVD Study: An accelerated delivery of Adriamycin, Bleomycin, Vinblastin and Dacarbazine for patients with Hodgkin Lymphoma
- Conditions
- Early Stage Unfavourable Hodgkin LymphomaCancer - Hodgkin'sAdvanced Stage Hodgkin Lymphoma
- Registration Number
- ACTRN12612000137897
- Lead Sponsor
- Queensland Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 31
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the feasibility and safety of dose-dense ABVD in patients with early stage unfavourable and advanced stage Hodgkin lymphoma as measured by the proportion of patients completing all cycles on time without febrile neutropenia or grade IV thrombocytopenia as determined by serum assays[Completion of 4 cycles of ABVD for early stage unfavourable disease or up to 8 cycles of ABVD for advanced stage unfavourable disease];To determine the feasibility and safety of dose-dense ABVD in patients with early stage unfavourable and advanced stage Hodgkin lymphoma as measured by the proportion of patients with a clinical diagnosis of bleomycin lung toxicity made by the investigator. Since there are no histological or clinical findings which are pathognomonic for bleomycin-induced pneumonitis, the diagnosis must be made on the basis of clinical, radiological and/or histological findings after excluding other differential diagnoses.[At any time during the study period]
- Secondary Outcome Measures
Name Time Method To determine complete response rate as assessed by IWG )(International Working Group ) criteria[Final response to treatment will be evaluated 2 months after the completion of all treatment];To determine the progression free survival[At 2 and 5 years of follow-up after the completion of all treatment];To determine the overall survival[At 2 and 5 years of follow-up after the completion of all treatment];To assess the role of novel serum biomarkers (such as TARC, ALCAM, Galectin-1 and microRNAs) as tools to provide supplemental data to interim radiography, to assist clinicians in the management of Hodgkin Lymphoma[Samples will be obtained prior to first therapy, before each doxorubicin cycle, 2 weeks after completion of ABVD, and 2 months after completion of all therapy]