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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)

Primary Purpose

Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
ABVD
ABVD and Radiotherapy
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's lymphoma, ABVD, FDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography), Radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • Centro di riferimento Oncologico Oncologia Medica A
  • Università Policlinico di Bari - Divisione di Medicina A
  • Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica
  • Sezione di Ematologia Spedali Civili
  • Ospedale di Circolo SC Oncologia Medica III
  • Divisione di Ematologia Osp.Businco
  • Policlinico Careggi Cattedra di Ematologia
  • ASLTO4
  • Osp. Cardinale Panico Divisione di Ematologia Tricase
  • Ospedale Niguarda Cà Granda
  • Università Avogadro Divisione di Ematologia
  • Ospedale San Francesco UO Ematologia e Centro Trapianti
  • Fondazione Policlinico San Matteo Clinica Ematologica
  • Osp. Santa Maria delle Croci UO Ematologia
  • Ospedale Bianchi Melacrino Morelli
  • Osp. degli Infermi Divisione di Oncologia
  • Istituto Regina Elena IFO SC Ematologia
  • Osp.Sant'Eugenio Divisione di Ematologia
  • Università La Sapienza Dipartimento di Biotecnnologie Cellulari
  • Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia
  • AO Universitaria di Sassari
  • Policlinico Le Scotte
  • Struttura Complessa di Onco-Ematologia
  • IRCC Onco-Ematologia Candiolo
  • Osp. San Giovanni Battista_Molinette Ematologia 2
  • Azienda Ospedaliero universitaria di Udine
  • ASL 14 UO Oncologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm A

Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 3, 2008
Last Updated
February 7, 2018
Sponsor
Fondazione Italiana Linfomi - ETS
Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
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1. Study Identification

Unique Protocol Identification Number
NCT00784537
Brief Title
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
Acronym
HD0801
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Linfomi - ETS
Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is composed by two phases: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
Keywords
Hodgkin's lymphoma, ABVD, FDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography), Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Other
Arm Description
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.
Arm Title
Arm B
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ABVD
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
ABVD and Radiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Levis, MD
Organizational Affiliation
Ospedale SS. Antonio, Biagio e Cesare Arrigo
Official's Role
Study Director
Facility Information:
Facility Name
Centro di riferimento Oncologico Oncologia Medica A
City
Aviano
Country
Italy
Facility Name
Università Policlinico di Bari - Divisione di Medicina A
City
Bari
Country
Italy
Facility Name
Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica
City
Bologna
Country
Italy
Facility Name
Sezione di Ematologia Spedali Civili
City
Brescia
Country
Italy
Facility Name
Ospedale di Circolo SC Oncologia Medica III
City
Busto Arsizio
Country
Italy
Facility Name
Divisione di Ematologia Osp.Businco
City
Cagliari
Country
Italy
Facility Name
Policlinico Careggi Cattedra di Ematologia
City
Firenze
Country
Italy
Facility Name
ASLTO4
City
Ivrea
Country
Italy
Facility Name
Osp. Cardinale Panico Divisione di Ematologia Tricase
City
Lecce
Country
Italy
Facility Name
Ospedale Niguarda Cà Granda
City
Milano
Country
Italy
Facility Name
Università Avogadro Divisione di Ematologia
City
Novara
Country
Italy
Facility Name
Ospedale San Francesco UO Ematologia e Centro Trapianti
City
Nuoro
Country
Italy
Facility Name
Fondazione Policlinico San Matteo Clinica Ematologica
City
Pavia
Country
Italy
Facility Name
Osp. Santa Maria delle Croci UO Ematologia
City
Ravenna
Country
Italy
Facility Name
Ospedale Bianchi Melacrino Morelli
City
Reggio Calabria
Country
Italy
Facility Name
Osp. degli Infermi Divisione di Oncologia
City
Rimini
Country
Italy
Facility Name
Istituto Regina Elena IFO SC Ematologia
City
Roma
Country
Italy
Facility Name
Osp.Sant'Eugenio Divisione di Ematologia
City
Roma
Country
Italy
Facility Name
Università La Sapienza Dipartimento di Biotecnnologie Cellulari
City
Roma
Country
Italy
Facility Name
Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia
City
Rozzano (MI)
Country
Italy
Facility Name
AO Universitaria di Sassari
City
Sassari
Country
Italy
Facility Name
Policlinico Le Scotte
City
Siena
Country
Italy
Facility Name
Struttura Complessa di Onco-Ematologia
City
Terni
Country
Italy
Facility Name
IRCC Onco-Ematologia Candiolo
City
Torino
Country
Italy
Facility Name
Osp. San Giovanni Battista_Molinette Ematologia 2
City
Torino
Country
Italy
Facility Name
Azienda Ospedaliero universitaria di Udine
City
Udine
Country
Italy
Facility Name
ASL 14 UO Oncologia
City
Verbania
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34597375
Citation
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.
Results Reference
derived
PubMed Identifier
26884559
Citation
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.
Results Reference
derived

Learn more about this trial

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

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