NCT00877747

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

8.8 years

First QC Date

April 7, 2009

Last Update Submit

October 16, 2015

Conditions

Hodgkin Lymphoma

Keywords

PET

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    2 years

Secondary Outcomes (2)

  • Incidence of progression/relapse

    2 years

  • Interim PET positive and negative predictive value

    2 years

Study Arms (2)

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

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Santa Croce e Carle

Cuneo, 12100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 17646666BACKGROUND

  • Gallamini 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.

    PMID: 21166786DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andrea Gallamini, MD

    Azienda Ospedaliera Santa Croce e Carle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

January 1, 2006

Primary Completion

November 1, 2014

Study Completion

October 1, 2015

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

IT(1)