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Hodgkin's LymphomaPhase 2/3HD0801NCT00784537

High-dose Chemotherapy and Stem Cell Transplantation, in Patients PET-2 Positive, After 2 Courses of ABVD and Comparison of RT Versus no RT in PET-2 Negative Patients

A Phase 2/3 study testing ABVD and ABVD and Radiotherapy in people with Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 27 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hodgkin's Lymphoma
What is being tested?
ABVD and ABVD and Radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
27 sitesItaly
Study dates
Sep 2008to Jan 2016
Phase
Phase 2/3
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%).

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Italy27 sites

  • Centro di riferimento Oncologico Oncologia Medica A

    Aviano

  • Università Policlinico di Bari - Divisione di Medicina A

    Bari

  • Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica

    Bologna

  • Sezione di Ematologia Spedali Civili

    Brescia

  • Ospedale di Circolo SC Oncologia Medica III

    Busto Arsizio

  • Divisione di Ematologia Osp.Businco

    Cagliari

  • Policlinico Careggi Cattedra di Ematologia

    Florence

  • ASLTO4

    Ivrea

  • Osp. Cardinale Panico Divisione di Ematologia Tricase

    Lecce

  • Ospedale Niguarda Cà Granda

    Milan

  • Università Avogadro Divisione di Ematologia

    Novara

  • Ospedale San Francesco UO Ematologia e Centro Trapianti

    Nuoro

  • Fondazione Policlinico San Matteo Clinica Ematologica

    Pavia

  • Osp. Santa Maria delle Croci UO Ematologia

    Ravenna

  • Ospedale Bianchi Melacrino Morelli

    Reggio Calabria

  • Osp. degli Infermi Divisione di Oncologia

    Rimini

  • Istituto Regina Elena IFO SC Ematologia

    Roma

  • Osp.Sant'Eugenio Divisione di Ematologia

    Roma

  • Università La Sapienza Dipartimento di Biotecnnologie Cellulari

    Roma

  • Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia

    Rozzano (MI)

  • AO Universitaria di Sassari

    Sassari

  • Policlinico Le Scotte

    Siena

  • Struttura Complessa di Onco-Ematologia

    Terni

  • IRCC Onco-Ematologia Candiolo

    Torino

  • Osp. San Giovanni Battista_Molinette Ematologia 2

    Torino

  • Azienda Ospedaliero universitaria di Udine

    Udine

  • ASL 14 UO Oncologia

    Verbania

Other trials in Italy

About this study

Official title: Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients

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.
Read the detailed description

This study is composed by two phases:

  1. A phase II multi-centre study evaluating in patients with advanced stage Hodgkin lymphoma the efficacy of an early salvage treatment with high-dose chemotherapy followed by stem cell transplantation in patients FDG-PET positive after two courses of ABVD (PET-2 positive).
  2. A phase III randomised study comparing the efficacy of radiotherapy to the areas of initial bulky disease versus no further therapy in PET-2 negative patients in complete remission (PET-6 negative) at the end of six courses of ABVD.
Being tested
ABVD, ABVD and Radiotherapy
Keywords
Hodgkin's lymphoma, ABVD, FDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography), Radiotherapy
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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).

Study groups in NCT00784537
Study groupRoleWhat they receive
Arm AOtherTwo 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.
Receives: Drug: ABVD
Arm BOtherTwo 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.
Receives: Drug: ABVD and Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 years

Secondary outcomes (1)

  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.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJan 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00784537
Sponsor's protocol ID
IIL-HD0801
Other IDs
EudracT Number 2008-002684-14
Acronym
HD0801
Status last verified
Feb 2018
First submitted
3 Nov 2008
Last updated
8 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40135712

  • 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.

    PubMed 34597375

  • 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.

    PubMed 26884559

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ABVD and ABVD and Radiotherapy in people with Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 27 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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. (time frame: 4 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 NCT00784537, which also lists 3 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 8 Feb 2018.

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