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 (HD0801)

February 7, 2018 updated by: Fondazione Italiana Linfomi ONLUS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Aviano, Italy
        • Centro di riferimento Oncologico Oncologia Medica A
      • Bari, Italy
        • Università Policlinico di Bari - Divisione di Medicina A
      • Bologna, Italy
        • Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica
      • Brescia, Italy
        • Sezione di Ematologia Spedali Civili
      • Busto Arsizio, Italy
        • Ospedale di Circolo SC Oncologia Medica III
      • Cagliari, Italy
        • Divisione di Ematologia Osp.Businco
      • Firenze, Italy
        • Policlinico Careggi Cattedra di Ematologia
      • Ivrea, Italy
        • ASLTO4
      • Lecce, Italy
        • Osp. Cardinale Panico Divisione di Ematologia Tricase
      • Milano, Italy
        • Ospedale Niguarda CA Granda
      • Novara, Italy
        • Università Avogadro Divisione di Ematologia
      • Nuoro, Italy
        • Ospedale San Francesco UO Ematologia e Centro Trapianti
      • Pavia, Italy
        • Fondazione Policlinico San Matteo Clinica Ematologica
      • Ravenna, Italy
        • Osp. Santa Maria delle Croci UO Ematologia
      • Reggio Calabria, Italy
        • Ospedale Bianchi Melacrino Morelli
      • Rimini, Italy
        • Osp. degli Infermi Divisione di Oncologia
      • Roma, Italy
        • Osp.Sant'Eugenio Divisione di Ematologia
      • Roma, Italy
        • Istituto Regina Elena IFO SC Ematologia
      • Roma, Italy
        • Università La Sapienza Dipartimento di Biotecnnologie Cellulari
      • Rozzano (MI), Italy
        • Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia
      • Sassari, Italy
        • AO Universitaria di Sassari
      • Siena, Italy
        • Policlinico Le Scotte
      • Terni, Italy
        • Struttura Complessa di Onco-Ematologia
      • Torino, Italy
        • IRCC Onco-Ematologia Candiolo
      • Torino, Italy
        • Osp. San Giovanni Battista_Molinette Ematologia 2
      • Udine, Italy
        • Azienda Ospedaliero universitaria di Udine
      • Verbania, Italy
        • ASL 14 UO Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Arm A

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

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)
OTHER: Arm B

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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Collaborators

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Investigators

  • Study Director: Alessandro Levis, MD, Ospedale SS. Antonio, Biagio e Cesare Arrigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (ESTIMATE)

November 4, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL-HD0801
  • EudracT Number 2008-002684-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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