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Trial registered on ANZCTR


Registration number
ACTRN12612000137897
Ethics application status
Not yet submitted
Date submitted
14/11/2011
Date registered
1/02/2012
Date last updated
1/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose-Dense ABVD Study: An accelerated delivery of Adriamycin, Bleomycin, Vinblastin and Dacarbazine for patients with Hodgkin Lymphoma
Scientific title
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.
Secondary ID [1] 273389 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Stage Unfavourable Hodgkin Lymphoma 279166 0
Advanced Stage Hodgkin Lymphoma 285717 0
Condition category
Condition code
Cancer 279360 279360 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For early stage unfavourable disease: 4 cycles of ABVD plus 30.6Gy IF-XRT (extended field radiation therapy)

Adriamycin at 25mg/m2 intravenous on day 1 and 12 of a 21 day cycle
Bleomycin at 10,000 IU/m2 intravenous on day 1 and 12 of a 21 day cycle
Vinblastine at 6mg/m2 intravenous on day 1 and 12 of a 21 day cycle
Dacarbazine at 375mg/m2 intravenous on day 1 and 12 of a 21 day cycle
Nivestim at 300 microgram subcutaneous on days 4-8 and 15-19 of a 21 day cycle

CT restaging after chemotherapy should take place 2 weeks of the end of chemotherapy with irradiation ( 30.6Gy IF-XRT in 17 fractions at 5/week using 1.8Gy daily dose) beginning after recovery of blood counts (ANC > 1.0 x 109/L, platelets > 75), 4 weeks if possible but at most 6 weeks after the end of chemotherapy.

For advanced stage: 6-8 cycles of ABVD

Adriamycin at 25mg/m2 intravenous on day 1 and 12 of a 21 day cycle
Bleomycin at 10,000 IU/m2 intravenous on day 1 and 12 of a 21 day cycle
Vinblastine at 6mg/m2 intravenous on day 1 and 12 of a 21 day cycle
Dacarbazine at 375mg/m2 intravenous on day 1 and 12 of a 21 day cycle
Nivestim at 300 microgram subcutaneous on days 4-8 and 15-19 of a 21 day cycle

Advanced stage patients who are in CR or Cru after interim CT restaging (i.e. after 3 or 4 cycles) are to receive 6 cycles whereas those with ongoing response between interim CT restaging and CT staging after 6 cycles should go on to receive a further 2 cycles of ABVD to a total of 8 cycles.
Intervention code [1] 283718 0
Treatment: Drugs
Intervention code [2] 284154 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 285950 0
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
Timepoint [1] 285950 0
Completion of 4 cycles of ABVD for early stage unfavourable disease or up to 8 cycles of ABVD for advanced stage unfavourable disease
Primary outcome [2] 285951 0
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.
Timepoint [2] 285951 0
At any time during the study period
Secondary outcome [1] 294830 0
To determine complete response rate as assessed by IWG )(International Working Group ) criteria
Timepoint [1] 294830 0
Final response to treatment will be evaluated 2 months after the completion of all treatment
Secondary outcome [2] 294831 0
To determine the progression free survival
Timepoint [2] 294831 0
At 2 and 5 years of follow-up after the completion of all treatment
Secondary outcome [3] 294832 0
To determine the overall survival
Timepoint [3] 294832 0
At 2 and 5 years of follow-up after the completion of all treatment
Secondary outcome [4] 294833 0
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
Timepoint [4] 294833 0
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

Eligibility
Key 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
Minimum age
16 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once consented, patients must be registered prior to starting treatment. Clinical staging, inclusion and exclusion criteria, and signed consent will be checked. This process will be completed using the online clinical trials system maintained by the Queensland Clinical Trials & Biostatistics Centre. A confirmation email will be sent to the investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 4734 0
4006
Recruitment postcode(s) [2] 4735 0
4102
Recruitment postcode(s) [3] 4736 0
4215
Recruitment postcode(s) [4] 4737 0
4101
Recruitment postcode(s) [5] 4738 0
4560
Recruitment postcode(s) [6] 4739 0
4814

Funding & Sponsors
Funding source category [1] 284204 0
Commercial sector/Industry
Name [1] 284204 0
Hospira
Address [1] 284204 0
Level 3, 500 Collins Street
Melbourne VIC 3000
Country [1] 284204 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 269161 0
None
Name [1] 269161 0
Address [1] 269161 0
Country [1] 269161 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286165 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 286165 0
Building 35, Level 2
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [1] 286165 0
Australia
Date submitted for ethics approval [1] 286165 0
17/11/2011
Approval date [1] 286165 0
Ethics approval number [1] 286165 0
HREC/11/QPAH/629

Summary
Brief summary
This study will evaluate whether giving standard chemotherapy treatment more quickly can be done safely and will be more effective in treating patients with Hodgkin Lymphoma.

Who is it for?
You may be eligible to join this study if you are aged between 16-60 years and have been diagnosed with either early stage unfavourable or advanced stage Hodgkin Lymphoma.

Trial details
The current standard therapy for Hodgkin Lymphoma involves receiving a four drug chemotherapy regimen called 'ABVD' every fourteen days. ABVD is an abbreviation for the four drugs used (A=adriamycin, B=bleomycin, V=vinblastin, D=dacarbazine). This chemotherapy is generally well tolerated. A full cycle of therapy involves ABVD given on days 1 and 15 of a 28 day (=4 week) cycle. In this trial, all participants! will receive the exact same four drug combination (ABVD) but given on days 1 and 12 of a 21 day (=3 week) cycle. A growth factor called Nivestim will be given to accelerate the recovery of the body's normal blood cells from the effects of ABVD and thus allow the chemotherapy to be given more quickly than usual. Participants will undergo between 4 to 8 cycles of treatment depending on response.

Participants will be regularly assessed over a period of up to 5 years to determine the safety and efficacy of this accelerated chemotherapy regime.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33390 0
Address 33390 0
Country 33390 0
Phone 33390 0
Fax 33390 0
Email 33390 0
Contact person for public queries
Name 16637 0
Peter Mollee
Address 16637 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 16637 0
Australia
Phone 16637 0
+61 7 3176 2111
Fax 16637 0
+61 7 3176 7042
Email 16637 0
peter_mollee@health.qld.gov.au
Contact person for scientific queries
Name 7565 0
Peter Mollee
Address 7565 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 7565 0
Australia
Phone 7565 0
+61 7 3176 2111
Fax 7565 0
+61 7 3176 7042
Email 7565 0
peter_mollee@health.qld.gov.au

No data has been provided for results reporting
Summary results
Not applicable