Back to results

FIL Study on ABVD DD-DI as Upfront Therapy in HL.

Primary Purpose

Hodgkin Lymphoma

Status

Active

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Doxorubicin

Bleomycin

Vinblastine

Dacarbazine

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring advanced stage (IIB-IV), ABVD DD-DI, PET

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed classical HL
Previously untreated disease
Age 18-60 years
Ann Arbor stage IIB with extranodal involvement and/or mediastinal bulk, III and IV (Appendix A)
At least one target PET-avid bidimensionally assessable lesion
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2 (Appendix B)
Adequate organ and marrow function as defined below: absolute neutrophil count >1,0 x109/L, platelets >75 x109/L
Total bilirubin <2 mg/dl without a pattern consistent with Gilbert's syndrome
Aspartate Transaminase and Alanine Transaminase (AST/ALT) <3 X institutional Upper Limits of Normality (ULN)
Creatinine within normal institutional limits or creatinine clearance >50 mL/min/1.72 m2 (Appendix C)
Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception
Life expectancy > 6 months
Able to adhere to the study visit schedule and other protocol requirements
Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Access to PET-CT scans facilities qualified by FIL

Exclusion Criteria:

Nodular Lymphocyte Predominant HL
Ann Arbor stage IIB without extranodal involvement and/or mediastinal bulky
Prior chemotherapy or radiation therapy
Pregnant or lactating females
Known hypertension (as defined by the updated Guidelines [76]), cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.
Abnormal QTc interval prolonged (>450 msec in males; >470 msec in women)
Diffusion lung capacity for CO (DLCO) and/or forced expiratory volume in the 1st second (FEV1) tests <50% of predicted not related to impaired respiratory capacity due to airway compression by mediastinal masses or parenchymal lymphoma
Known cerebral or meningeal disease (HL or any other etiology)
Prior history of malignancies unless the patient has been free of the disease for five years. Exceptions include the following: basal cells carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast and prostate cancer with TNM stage of T1a or T1b
Uncontrolled infectious disease
Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided
Uncompensated diabetes
Refusal of adequate contraception
Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.

Sites / Locations

A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Università Politecnica delle Marche, Clinica di Ematologia
Ospedale C.e G. Mazzoni -U.O.C. di Ematologia
Azienda Ospedaliera S.Giuseppe Moscati -S.C. Ematologia e Trapianto emopoietico
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
AOU Policlinico Consorziale - U.O. Ematologia con Trapianto
IRCCS Istituto Tumori Giovanni Paolo II
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
A.O. Spedali Civili di Brescia - Ematologia
Ospedale Antonio Perrino - Ematologia
Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia
AORN S.Anna e S. Sebastiano - Oncoematologia
Ospedale di Castelfranco Veneto - Ematologia
ASST Cremona - Ematologia e CRTO
Ospedali Riuniti del Canavese
Ospedale Vito Fazzi - Ematologia
Ospedale Madonna delle Grazie - Ematologia
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
USLL13 - Dipartimento di Scienze Mediche UOC di Oncologia ed Ematologia Oncologica
Azienda Ospedaliero-Universitaria Policlinico di Modena - Ematologia
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - Ematologia Oncologica
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Presidio ospedaliero "A. TORTORA"
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
AOU di Parma - UO Ematologia e CTMO
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
AO di Perugia - Ematologia
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Ospedale Guglielmo da Saliceto - U.O.Ematologia
A.O.R. "San Carlo" - U.O. Ematologia
Ospedale delle Croci - Ematologia
Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS c/o CORE (II piano)
Ospedale degli Infermi di Rimini
IRCCS-Centro di riferimento oncologico - UO di ematologia e Trapianto Cellule Staminali
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Biotecnologie Cellulari ed Ematologia
Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare"
Università Cattolica S. Cuore - Ematologia
Istituto Clinico Humanitas - U.O. Ematologia
Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D'Aragona - U.O. Ematologia
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Univ. Perugia Sede Terni - Oncoematologia
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia
A.O. C. Panico - U.O.C Ematologia e Trapianto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Comparator arm

Experimental arm

Arm Description

Patients will receive 2 courses of standard ABVD (ABVD-28, d1, d15, cycles of 28 days) and then proceed to interim PET/CT evaluation. Those with a PET-2-negative scan (score 1-3 on 5PS) will continue with additional 4 ABVD courses while those with a PET-2-positive (score 4-5) scan will be diverted towards an intensification phase with either escalated BEACOPP or HDT plus ASCR, according to the preference of the centre. Upon completion of treatment, patients will be categorized for response (Lugano2014) by comparing actual PET/CT imaging with baseline, whether 6 ABVD cycles or ABVDx2 + intensification phase with BEACOPP or HDT/ASCR. A salvage rescue program will be planned for patients with Stable (<PR) or Progressive Disease. ISRT 30 Gy will be delivered to complete responders (5PS score 1-2-3) on the initial bulky site(s), to focal rests in case of CR scoring 3 on 5PS with a residual size ≥ 2.5 cm and to focal rests uptakes in the event of PR scoring 4 or 5, whichever is the size.

Dose-dense and dose-intense ABVD regimen (ABVD DD-DI: intercycle 21 days, d1, d11; doxorubicin 35 mg/m2 DD 1 and 11) is given in cycles 1 to 4 and dose-dense ABVD (ABVD DD: intercycle 21 days, D1 and D11; conventional doxorubicin dose, e.g. 25 mg/m2 DD 1 and 11) is given as cycles 5 and 6). The treatment is not PET-adapted, and only patients with no response or progressive disease at interim FDG-PET as defined by the Lugano Classification (e.g., score 4 or 5 on 5PS with no significant change or with increased uptake matched with baseline and/or new FDG-avid foci consistent with lymphoma) will be diverted to salvage therapy. ISRT 30 Gy will be delivered to responder patients (DS=3), on focal PET-positive rests with a residual size ≥ 2.5 cm and on patients in PR with uptake scoring 4 or 5, whichever is the size.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS is defined as the interval elapsing from randomization until lymphoma progression or death as a result of any cause.

Secondary Outcome Measures

Complete remission rate (CR rate)

CR rate is defined as the proportion of patients achieving a CR after 2 months of chemotherapy (interim) and at the end of treatment

PET/CT response rate

Event Free Survival (EFS)

EFS will be measured from the time from entry onto a study to any treatment failure including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of new treatment lacking documented progression, or death)

Disease free survival (DFS)

DFS will be measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment

Overall survival (OS)

OS is defined as the time from entry onto the clinical trial until death as a result of any cause

Toxicity

Acute severe toxicity, acute and delayed pulmonary toxicity, acute and delayed cardiac toxicity. Late toxicity and second malignancies. The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions).

Quality of life (QoL)

QoL will be measured at the baseline, the end of therapy and during follow-up through the EORTC QLQ-C30 questionnaire

Cost-effectiveness analyses

Cost-effectiveness analyses. ICER will be calculated by dividing the difference in mean total costs arms by the difference in the mean effects. The ICER will be calculated for the principal clinical effect measures of the trial. (i.e. PFS) and for QALYs. QALYs will be calculated multiplying the amount of time a patient spent in a particular health state by the utilities estimated using the EQ-5D questionnaires

Full Information

NCT ID

NCT03159897

First Posted

May 15, 2017

Last Updated

September 13, 2023

Sponsor

Fondazione Italiana Linfomi - ETS

1. Study Identification

Unique Protocol Identification Number

NCT03159897

Brief Title

FIL Study on ABVD DD-DI as Upfront Therapy in HL.

Official Title

A Randomized, Open-label, Multicenter, Phase III, 2-arm Study Comparing Efficacy and Tolerability of the Intensified Variant 'Dose-dense/Dose-intense ABVD' (ABVD DD-DI) With an Interim PET Response-adapted ABVD Program as Upfront Therapy in Advanced-stage Classical Hodgkin Lymphoma (HL).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

November 2, 2021 (Actual)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione Italiana Linfomi - ETS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The FIL-Rouge is a randomized, open-label, multicenter, phase III, 2-arm study. The primary objective is to compare efficacy and tolerability of the intensified variant 'dose-dense/dose-intense ABVD' (ABVD DD-DI) with an interim PET response-adapted ABVD program as upfront therapy in advanced-stage classical Hodgkin Lymphoma (HL).

Detailed Description

The study is devoted to patients affected with advanced stage (IIB-IV) Hodgkin Lymphoma. The study aims to compare the efficacy of two alternative ABVD-based strategies, the first one (Comparator arm) based on a PET-2-adaptation, the second (Experimental arm) relying on a straight dose- and time-intensified schedule, devoid of any PET-adaptation. In the Comparator arm, the patients will receive two courses of standard ABVD (ABVD-28). Those with a PET-2 negative scan (Deauville Score 1-3) will proceed with additional 4 ABVD courses while those with a PET-2-positive scan (Deauville score 4-5) will be diverted towards a deferred intensification with either escalated BEACOPP or HDT plus ASCR , according to the preference of the Center. In the Experimental arm, patients are treated with three cycles of a dose-dense/dose-intense ABVD (ABVD DD-DI) [e.g. a modified ABVD including the single escalation of doxorubicin to 35 mg/m2 (70 mg/m2 per cycle) and a three-weekly recycle time for all drugs (e.g. administration of all 4 drugs at days 1 and 11 of each cycle)]. Those with a progressive disease or non-responder patients according to PET/CT imaging at interim evaluation (after cycle 3) as categorized with Lugano 2014 Classification will be diverted to salvage strategies. The other patients will receive one additional course of ABVD DD-DI followed by two courses of dose-dense three-weekly ABVD (ABVD DD) (e.g. administration of all four drugs at days 1 and 11 of each cycle at the conventional doses, including doxorubicin at 25 mg/m2). In both treatment arms 30 Gy Involved Site Radiotherapy (ISRT) is scheduled for those patients PET-negative (DS=3) with residual tumor rests ≥ 2.5 cm and for PET-positive patients in PR (DS= 4 or 5) regardless of the size of the rests. The single reference dose is 2.0 Gy daily and fractionation is five times per week. Only in the Comparator arm the patients in CR (final score 1-3 according to 5PS by central review panel decision) will receive adjuvant ISRT at the initial bulky site(s) for a total reference dose of 30 Gy in single daily fractions of 2.0 Gy, five times weekly. Blinded independent central reviewing for PET imaging will supervise response categorization at interim and final PET/CT evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma

Keywords

advanced stage (IIB-IV), ABVD DD-DI, PET

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

The study aims to compare the efficacy of two alternative ABVD-based strategies, the first one (Comparator arm) based on a PET-2-adaptation, the second (Experimental arm) relying on a straight dose- and time-intensified schedule, devoid of any PET-adaptation.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Comparator arm

Arm Type

Experimental

Arm Description

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

Comparator arm: cycle 1-2 (and eventually 3-6): 25 mg/m2 i.v. days 1,15. Experimental arm: Cycles 1 to 4: 35 mg/m2 i.v. days 1,11. Cycles 5 and 6: 25 mg/m2 i.v. days 1,11.

Intervention Type

Drug

Intervention Name(s)

Bleomycin

Intervention Description

Bleomicina Comparator arm: cycle 1-2 (and eventually 3-6): 10,000 units/m2 i.v. days 1,15. Experimental arm: cycles 1 to 4: 10,000 units/m2 i.v. days 1,11. Cycles 5 and 6: 10,000 units/m2 i.v. days 1,11.

Intervention Type

Drug

Intervention Name(s)

Vinblastine

Intervention Description

Vinblastina Comparator arm: cycle 1-2 (and eventually 3-6): 6 mg/m2 i.v. days 1,15. Experimental arm: cycles 1 to 4: 6 mg/m2 i.v. days 1,11. Cycles 5 and 6: 6 mg/m2 i.v. days 1,11.

Intervention Type

Drug

Intervention Name(s)

Dacarbazine

Intervention Description

Dacarbazina Comparator arm: cycle 1-2 (and eventually 3-6): 375 mg/m2 i.v. days 1,15. Experimental arm: cycles 1 to 4: 375 mg/m2 i.v. days 1,11. Cycles 5 and 6: 375 mg/m2 i.v. days 1,11.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

PFS is defined as the interval elapsing from randomization until lymphoma progression or death as a result of any cause.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Complete remission rate (CR rate)

Description

CR rate is defined as the proportion of patients achieving a CR after 2 months of chemotherapy (interim) and at the end of treatment

Time Frame

2 months and 6 months

Title

PET/CT response rate

Description

PET/CT response rate

Time Frame

after 2 months of chemotherapy

Title

Event Free Survival (EFS)

Description

Time Frame

3 years

Title

Disease free survival (DFS)

Description

DFS will be measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment

Time Frame

3 years

Title

Overall survival (OS)

Description

OS is defined as the time from entry onto the clinical trial until death as a result of any cause

Time Frame

3 years

Title

Toxicity

Description

Time Frame

6 months for acute toxicity and 5 years for late toxicity

Title

Quality of life (QoL)

Description

QoL will be measured at the baseline, the end of therapy and during follow-up through the EORTC QLQ-C30 questionnaire

Time Frame

36 months

Title

Cost-effectiveness analyses

Description

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed classical HL Previously untreated disease Age 18-60 years Ann Arbor stage IIB with extranodal involvement and/or mediastinal bulk, III and IV (Appendix A) At least one target PET-avid bidimensionally assessable lesion Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2 (Appendix B) Adequate organ and marrow function as defined below: absolute neutrophil count >1,0 x109/L, platelets >75 x109/L Total bilirubin <2 mg/dl without a pattern consistent with Gilbert's syndrome Aspartate Transaminase and Alanine Transaminase (AST/ALT) <3 X institutional Upper Limits of Normality (ULN) Creatinine within normal institutional limits or creatinine clearance >50 mL/min/1.72 m2 (Appendix C) Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception Life expectancy > 6 months Able to adhere to the study visit schedule and other protocol requirements Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Access to PET-CT scans facilities qualified by FIL Exclusion Criteria: Nodular Lymphocyte Predominant HL Ann Arbor stage IIB without extranodal involvement and/or mediastinal bulky Prior chemotherapy or radiation therapy Pregnant or lactating females Known hypertension (as defined by the updated Guidelines [76]), cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography. Abnormal QTc interval prolonged (>450 msec in males; >470 msec in women) Diffusion lung capacity for CO (DLCO) and/or forced expiratory volume in the 1st second (FEV1) tests <50% of predicted not related to impaired respiratory capacity due to airway compression by mediastinal masses or parenchymal lymphoma Known cerebral or meningeal disease (HL or any other etiology) Prior history of malignancies unless the patient has been free of the disease for five years. Exceptions include the following: basal cells carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast and prostate cancer with TNM stage of T1a or T1b Uncontrolled infectious disease Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided Uncompensated diabetes Refusal of adequate contraception Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Pinto, MD

Organizational Affiliation

Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - Napoli

Official's Role

Principal Investigator

Facility Information:

Facility Name

A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia

City

Alessandria

Country

Italy

Facility Name

Università Politecnica delle Marche, Clinica di Ematologia

City

Ancona

Country

Italy

Facility Name

Ospedale C.e G. Mazzoni -U.O.C. di Ematologia

City

Ascoli Piceno

Country

Italy

Facility Name

Azienda Ospedaliera S.Giuseppe Moscati -S.C. Ematologia e Trapianto emopoietico

City

Avellino

Country

Italy

Facility Name

Centro Riferimento Oncologico - S.O.C. Oncologia Medica A

City

Aviano

Country

Italy

Facility Name

AOU Policlinico Consorziale - U.O. Ematologia con Trapianto

City

Bari

Country

Italy

Facility Name

IRCCS Istituto Tumori Giovanni Paolo II

City

Bari

Country

Italy

Facility Name

Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

City

Barletta

Country

Italy

Facility Name

A.O. Spedali Civili di Brescia - Ematologia

City

Brescia

Country

Italy

Facility Name

Ospedale Antonio Perrino - Ematologia

City

Brindisi

Country

Italy

Facility Name

Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia

City

Candiolo

Country

Italy

Facility Name

AORN S.Anna e S. Sebastiano - Oncoematologia

City

Caserta

Country

Italy

Facility Name

Ospedale di Castelfranco Veneto - Ematologia

City

Castelfranco Veneto

Country

Italy

Facility Name

ASST Cremona - Ematologia e CRTO

City

Cremona

Country

Italy

Facility Name

Ospedali Riuniti del Canavese

City

Ivrea

Country

Italy

Facility Name

Ospedale Vito Fazzi - Ematologia

City

Lecce

Country

Italy

Facility Name

Ospedale Madonna delle Grazie - Ematologia

City

Matera

Country

Italy

Facility Name

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia

City

Meldola

Country

Italy

Facility Name

Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia

City

Messina

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

City

Milano

Country

Italy

Facility Name

USLL13 - Dipartimento di Scienze Mediche UOC di Oncologia ed Ematologia Oncologica

City

Mirano

Country

Italy

Facility Name

Azienda Ospedaliero-Universitaria Policlinico di Modena - Ematologia

City

Modena

Country

Italy

Facility Name

Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - Ematologia Oncologica

City

Napoli

Country

Italy

Facility Name

I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Presidio ospedaliero "A. TORTORA"

City

Pagani

Country

Italy

Facility Name

A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

City

Palermo

Country

Italy

Facility Name

AOU di Parma - UO Ematologia e CTMO

City

Parma

Country

Italy

Facility Name

IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

City

Pavia

Country

Italy

Facility Name

AO di Perugia - Ematologia

City

Perugia

Country

Italy

Facility Name

P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

City

Pescara

Country

Italy

Facility Name

Ospedale Guglielmo da Saliceto - U.O.Ematologia

City

Piacenza

Country

Italy

Facility Name

A.O.R. "San Carlo" - U.O. Ematologia

City

Potenza

Country

Italy

Facility Name

Ospedale delle Croci - Ematologia

City

Ravenna

Country

Italy

Facility Name

Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS c/o CORE (II piano)

City

Reggio Emilia

Country

Italy

Facility Name

Ospedale degli Infermi di Rimini

City

Rimini

Country

Italy

Facility Name

IRCCS-Centro di riferimento oncologico - UO di ematologia e Trapianto Cellule Staminali

City

Rionero in Vulture

Country

Italy

Facility Name

Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Biotecnologie Cellulari ed Ematologia

City

Roma

Country

Italy

Facility Name

Policlinico Universitario Campus Bio-Medico - "Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare"

City

Roma

Country

Italy

Facility Name

Università Cattolica S. Cuore - Ematologia

City

Roma

Country

Italy

Facility Name

Istituto Clinico Humanitas - U.O. Ematologia

City

Rozzano (MI)

Country

Italy

Facility Name

Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D'Aragona - U.O. Ematologia

City

Salerno

Country

Italy

Facility Name

Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico

City

Sassuolo

Country

Italy

Facility Name

Univ. Perugia Sede Terni - Oncoematologia

City

Terni

Country

Italy

Facility Name

A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria

City

Torino

Country

Italy

Facility Name

A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia

City

Torino

Country

Italy

Facility Name

A.O. C. Panico - U.O.C Ematologia e Trapianto

City

Tricase

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

FIL Study on ABVD DD-DI as Upfront Therapy in HL.

We'll reach out to this number within 24 hrs