Hodgkin LymphomaNCT00877747
Early Chemotherapy Intensification in Interim-Positron Emission Tomography (PET) Positive Hodgkin Lymphoma
An observational study of Hodgkin Lymphoma, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
Trial summary
Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Hodgkin Lymphoma
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced stage Hodgkin's lymphoma (IIB to IVB) or in stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion)
Who may be able to join
- Patients with advanced Hodgkin's lymphoma according to the World Health Organization classification
- Age 16-80
- Not previously treated
- Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion)
- Written informed consent
Who cannot join
- Patients aged more than 80
- Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma
- Psychiatric disorders
- Uncontrolled infectious disease
- Impaired cardiac (EF < 50%) or renal (creatinine clearance < 60 ml/m)function
- Pregnancy and lactation
- Uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study
Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2 positive patients is only 12%, but the optimal treatment for this patient subset is still unknown.
From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.
- Conditions
- Hodgkin Lymphoma
- Keywords
- PET
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PET2 negative | Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD | |
| PET2 positive | Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 2 years
Secondary outcomes (2)
Incidence of progression/relapse
Measured: 2 years
Interim PET positive and negative predictive value
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startJan 2006
- Primary completionNov 2014
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Croce-Carle Cuneo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo
- Investigators
- Andrea Gallamini, MD, Principal investigator, Azienda Ospedaliera Santa Croce e Carle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877747
- Sponsor's protocol ID
- HD-PET-intens-retr
- Status last verified
- Oct 2015
- First submitted
- 7 Apr 2009
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, Patti C, Loft A, Di Raimondo F, D'Amore F, Biggi A, Vitolo U, Stelitano C, Sancetta R, Trentin L, Luminari S, Iannitto E, Viviani S, Pierri I, Levis A. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol. 2007 Aug 20;25(24):3746-52. doi: 10.1200/JCO.2007.11.6525. Epub 2007 Jul 23.
PubMed 17646666Gallamini A, Patti C, Viviani S, Rossi A, Fiore F, Di Raimondo F, Cantonetti M, Stelitano C, Feldman T, Gavarotti P, Sorasio R, Mule A, Leone M, Rambaldi A, Biggi A, Barrington S, Fallanca F, Ficola U, Chauvie S, Gianni AM; Gruppo Italiano Terapie Innovative nei Linfomi (GITIL). Early chemotherapy intensification with BEACOPP in advanced-stage Hodgkin lymphoma patients with a interim-PET positive after two ABVD courses. Br J Haematol. 2011 Mar;152(5):551-60. doi: 10.1111/j.1365-2141.2010.08485.x. Epub 2010 Dec 20.
PubMed 21166786
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT00877747
- Acronym / sponsor ID
- HD-PET-intens-retr
- Conditions
- Hodgkin Lymphoma
- Keywords
- PET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ospedale Santa Croce-Carle CuneoUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2014 (actual)
- Study completion
- Oct 2015 (estimated)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2 positive patients is only 12%, but the optimal treatment for this patient subset is still unknown.
From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET2 negative | – | –Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD |
| PET2 positive | – | –Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced stage Hodgkin's lymphoma (IIB to IVB) or in stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion)
Key inclusion criteria (5 listed)
- Patients with advanced Hodgkin's lymphoma according to the World Health Organization classification
- Age 16-80
- Not previously treated
- Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion)
- Written informed consent
Key exclusion criteria (7 listed)
- Patients aged more than 80
- Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma
- Psychiatric disorders
- Uncontrolled infectious disease
- Impaired cardiac (EF < 50%) or renal (creatinine clearance < 60 ml/m)function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free Survival
Time frame: 2 years
2 secondary outcomes
Incidence of progression/relapse
Time frame: 2 years
Interim PET positive and negative predictive value
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Background: PubMed 17646666Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, Patti C, Loft A, Di Raimondo F, D'Amore F, Biggi A, Vitolo U, Stelitano C, Sancetta R, Trentin L, Luminari S, Iannitto E, Viviani S, Pierri I, Levis A. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol. 2007 Aug 20;25(24):3746-52. doi: 10.1200/JCO.2007.11.6525. Epub 2007 Jul 23.
- Derived from this study: PubMed 21166786Gallamini A, Patti C, Viviani S, Rossi A, Fiore F, Di Raimondo F, Cantonetti M, Stelitano C, Feldman T, Gavarotti P, Sorasio R, Mule A, Leone M, Rambaldi A, Biggi A, Barrington S, Fallanca F, Ficola U, Chauvie S, Gianni AM; Gruppo Italiano Terapie Innovative nei Linfomi (GITIL). Early chemotherapy intensification with BEACOPP in advanced-stage Hodgkin lymphoma patients with a interim-PET positive after two ABVD courses. Br J Haematol. 2011 Mar;152(5):551-60. doi: 10.1111/j.1365-2141.2010.08485.x. Epub 2010 Dec 20.
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Gallamini, MD principal investigator
Azienda Ospedaliera Santa Croce e Carle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.