NCT00784537

Brief Summary

The purpose of this study is to define an improvement in patients:

  • To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue
  • To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_2

Geographic Reach
1 country

27 active sites

Status
completed

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

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

6.3 years

First QC Date

November 3, 2008

Last Update Submit

February 7, 2018

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's lymphomaABVDFDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography)Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue.

    4 years

Secondary Outcomes (1)

  • To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD.

    4 years

Study Arms (2)

Arm A

OTHER

Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: * PET-2 positive patients will be high-dose salvage treatment; * PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: * Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. * Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). PET-6 negative patients will be randomized to first arm: No radiotherapy.

Drug: ABVD

Arm B

OTHER

Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: * PET-2 positive patients will be high-dose salvage treatment; * PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: * Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. * Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). PET-6 negative patients will be randomized to second arm: Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease.

Drug: ABVD and Radiotherapy

Interventions

ABVDDRUG

ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm A (Observation)

Arm A
ABVD and RadiotherapyDRUG

ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk).

Arm B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed Hodgkin's lymphoma of the classical type (nodular lymphocyte predominance excluded).
  • Stage IIB-IV.
  • Age 18-70.
  • No prior therapy for Hodgkin's lymphoma
  • Written informed consent.
  • ECOG performance status grades 0-3 (see Appendix E).
  • FDG-PET scan before the initiation of treatment.

You may not qualify if:

  • Prior therapy for Hodgkin's lymphoma.
  • Age less than 18 or more than 70.
  • Other concomitant or prior malignancies, except basal cell skin carcinoma, or adequately treated carcinoma in situ of the cervix, or any cancer in complete remission for more than 5 years.
  • HIV infection.
  • Pregnancy or breast-feeding.
  • Renal failure (creatinine ≥2 times the normal value), liver failure (AST/ALT or bilirubine ≥ 2.5 times the normal value) or heart failure (NYHA class ≥ 2 or FEV \< 45%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Centro di riferimento Oncologico Oncologia Medica A

Aviano, Italy

Location

Università Policlinico di Bari - Divisione di Medicina A

Bari, Italy

Location

Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica

Bologna, Italy

Location

Sezione di Ematologia Spedali Civili

Brescia, Italy

Location

Ospedale di Circolo SC Oncologia Medica III

Busto Arsizio, Italy

Location

Divisione di Ematologia Osp.Businco

Cagliari, Italy

Location

Policlinico Careggi Cattedra di Ematologia

Florence, Italy

Location

ASLTO4

Ivrea, Italy

Location

Osp. Cardinale Panico Divisione di Ematologia Tricase

Lecce, Italy

Location

Ospedale Niguarda Cà Granda

Milan, Italy

Location

Università Avogadro Divisione di Ematologia

Novara, Italy

Location

Ospedale San Francesco UO Ematologia e Centro Trapianti

Nuoro, Italy

Location

Fondazione Policlinico San Matteo Clinica Ematologica

Pavia, Italy

Location

Osp. Santa Maria delle Croci UO Ematologia

Ravenna, Italy

Location

Ospedale Bianchi Melacrino Morelli

Reggio Calabria, Italy

Location

Osp. degli Infermi Divisione di Oncologia

Rimini, Italy

Location

Istituto Regina Elena IFO SC Ematologia

Roma, Italy

Location

Osp.Sant'Eugenio Divisione di Ematologia

Roma, Italy

Location

Università La Sapienza Dipartimento di Biotecnnologie Cellulari

Roma, Italy

Location

Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia

Rozzano (MI), Italy

Location

AO Universitaria di Sassari

Sassari, Italy

Location

Policlinico Le Scotte

Siena, Italy

Location

Struttura Complessa di Onco-Ematologia

Terni, Italy

Location

IRCC Onco-Ematologia Candiolo

Torino, Italy

Location

Osp. San Giovanni Battista_Molinette Ematologia 2

Torino, Italy

Location

Azienda Ospedaliero universitaria di Udine

Udine, Italy

Location

ASL 14 UO Oncologia

Verbania, Italy

Location

Related Publications (3)

  • Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.

    PMID: 40135712DERIVED

  • Ricardi U, Levis M, Evangelista A, Gioia DM, Sacchetti GM, Gotti M, Re A, Buglione M, Pavone V, Nardella A, Nassi L, Zanni M, Franzone P, Frezza GP, Pulsoni A, Grapulin L, Santoro A, Rigacci L, Simontacchi G, Tani M, Zaja F, Abruzzese E, Botto B, Zilioli VR, Rota-Scalabrini D, Freilone R, Ciccone G, Filippi AR, Zinzani PL. Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial. Blood Adv. 2021 Nov 9;5(21):4504-4514. doi: 10.1182/bloodadvances.2021005150.

    PMID: 34597375DERIVED

  • Zinzani PL, Broccoli A, Gioia DM, Castagnoli A, Ciccone G, Evangelista A, Santoro A, Ricardi U, Bonfichi M, Brusamolino E, Rossi G, Anastasia A, Zaja F, Vitolo U, Pavone V, Pulsoni A, Rigacci L, Gaidano G, Stelitano C, Salvi F, Rusconi C, Tani M, Freilone R, Pregno P, Borsatti E, Sacchetti GM, Argnani L, Levis A. Interim Positron Emission Tomography Response-Adapted Therapy in Advanced-Stage Hodgkin Lymphoma: Final Results of the Phase II Part of the HD0801 Study. J Clin Oncol. 2016 Apr 20;34(12):1376-85. doi: 10.1200/JCO.2015.63.0699. Epub 2016 Feb 16.

    PMID: 26884559DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

ABVD protocolRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Alessandro Levis, MD

    Ospedale SS. Antonio, Biagio e Cesare Arrigo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 4, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

IT(27)