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Trial registered on ANZCTR


Registration number
ACTRN12608000639325
Ethics application status
Approved
Date submitted
16/10/2008
Date registered
17/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicentre clinical study with early treatment intensification in patients with high-risk Hodgkin Lymphoma, identified as 18-F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) scan positive after two conventional Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) courses
Scientific title
This study evaluates the 3-year progression free survival (PFS) by using Positron Emission Tomography (PET)-adapted chemotherapy in advanced Hodgkin Lymphoma
Universal Trial Number (UTN)
Trial acronym
HD0607
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 3839 0
Condition category
Condition code
Blood 4104 4104 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants receive the initial therapy that consists in 2 courses of Doxorubicin (25 mg/m2 intravenous (iv) days 1,15), Bleomycin (10,000 units/m2 iv days 1,15), Vinblastine (6 mg/m2 iv days 1,15), Dacarbazine (375 mg/m2 iv days 1,15) (ABVD). After this two cycles (cycle repeats every 28 days) a early PET will be performed. If PET is positive the participants will be randomized to 4 (cycles repeat every 21 days) escalated Bleomycin (10 mg/m2/endovenous (ev)/day, day 8), Etoposide (200 mg/m2/ev/day, days 1-3), Doxorubicin (35 mg/m2/ev/day, day 1), Cyclophosphamide (1250 mg/m2/ev/day, day 1), Vincristine (1,4 mg/m2/ev/day, day 8), Procarbazine (100 mg/m2/b.m./day, days 1-7), Prednisone (40 mg/m2/b.m./day, days 1-14),(BEACOPPesc) or escalated Bleomycin (10 mg/m2/ev/day, day 8), Etoposide (200 mg/m2/ev/day, days 1-3), Doxorubicin (35 mg/m2/ev/day, day 1), Cyclophosphamide (1250 mg/m2/ev/day, day 1), Vincristine (1,4 mg/m2/ev/day, day 8), Procarbazine (100 mg/m2/b.m./day, days 1-7), Prednisone (40 mg/m2/b.m./die 1°-14°), Rituximab (375 mg/m2/ev/day, day 1) (R-BEACOPPesc). After participants will be received another PET.
Intervention code [1] 3565 0
Treatment: Drugs
Intervention code [2] 3630 0
Early detection / Screening
Comparator / control treatment
After two conventional courses of Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) patients who have a negative Positron Emission Tomography (PET) scan will be treated with other 4 courses of Doxorubicin (25 mg/m2 iv days 1,15), Bleomycin (10,000 units/m2 iv days 1,15), Vinblastine (6 mg/m2 iv days 1,15), Dacarbazine (375 mg/m2 iv days 1,15) (ABVD) Cycles repeat every 28 days. After participants will be received another PET.
Control group
Active

Outcomes
Primary outcome [1] 4929 0
3-year progression free survival (PFS) evaluated with a follow-up Case Report Form (CRF) each 6 months for 3 years
Timepoint [1] 4929 0
every 6 months for 3 years.
Secondary outcome [1] 8312 0
3-year event free survival (EFS) of all the registered patients whatever the treatment assigned. Events are deaths from any cause, disease progression, secondary cancer, late serious treatment-related events.
- Feasibility of the program for the entire population of advanced-stage Hodgkin Lymphoma patients admitted to Gruppo Italiano Terapia Innovativa nei Linfomi (GITIL) institutions evaluated with a follow-up Case Report Form (CRF) each 6 months for 3 years
Timepoint [1] 8312 0
every 6 months for 3 years.

Eligibility
Key inclusion criteria
-Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification
-Aged 18-60
-Not previously treated
-Stages IIB to IV B
-All International Prognostic Score (IPS) prognostic groups
-Patients who have signed an informed consent form
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients aged more than 60.
-Concomitant or previously treated neoplastic disorder less than 5 year before the diagnosis of Hodgkin’s lymphoma.
-Psychiatric disorders
-Uncontrolled infectious disease
-Impaired cardiac (Ejection Fraction (EF) < 50%) , renal (creatinine clearance < 60 ml/m)
-Human Immunodeficiency Virus (HIV) Hepatitis B Virus Deoxyribonucleic Acid(HBV DNA), Hepatitis C Virus Ribonucleic Acid (HCV RNA) positive markers
-Pregnancy and lactation
-Patients with uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors such as centre, age gender or previous treatment are used for the stratification.
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 1282 0
Italy
State/province [1] 1282 0

Funding & Sponsors
Funding source category [1] 4019 0
Charities/Societies/Foundations
Name [1] 4019 0
Gruppo Italiano Terapia Innovativa nei Linfomi
Country [1] 4019 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Gruppo Italiano Terapie Innovative nei Linfomi (GITIL)
Address
Via Schiaparelli, 23
12100 Cuneo
Country
Italy
Secondary sponsor category [1] 3612 0
None
Name [1] 3612 0
Address [1] 3612 0
Country [1] 3612 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6100 0
Comitato Etico Interaziendale dell'ASO Sante Croce e Carle di Cuneo
Ethics committee address [1] 6100 0
Ethics committee country [1] 6100 0
Italy
Date submitted for ethics approval [1] 6100 0
Approval date [1] 6100 0
16/05/2008
Ethics approval number [1] 6100 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29045 0
Address 29045 0
Country 29045 0
Phone 29045 0
Fax 29045 0
Email 29045 0
Contact person for public queries
Name 12202 0
Mariangela Saggese
Address 12202 0
Via Nazionale 8/A
66030 Santa Maria Imbaro (Chieti)
Country 12202 0
Italy
Phone 12202 0
0039-0872/570322
Fax 12202 0
0039-0872/570206
Email 12202 0
saggese@negrisud.it
Contact person for scientific queries
Name 3130 0
Mariangela Saggese
Address 3130 0
Via Nazionale 8/A
66030 Santa Maria Imbaro (Chieti)
Country 3130 0
Italy
Phone 3130 0
0039-0872/570322
Fax 3130 0
0039-0872/570206
Email 3130 0
saggese@negrisud.it , hd0607@negrisud.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.