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Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma

Primary Purpose

Hodgkin Lymphoma

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

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring HL, Hodgkin Lymphoma, First line therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18-70 years
  • Histologically confirmed Hodgkin Lymphoma stage I, II unfavorable according to EORTC (European Organisation for Research and Treatment of Cancer) criteria, with exclusion of stage II B bulky.
  • Previously untreated
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 - 2
  • Staging with FDG-PET (fluorodeoxyglucose positron emission tomography)
  • Written informed consent
  • Adequate liver and renal function (total serum bilirubin < 2.5 x ULN, AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine < 2.5 x ULN)

Exclusion Criteria:

  • Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease.
  • Uncontrolled diabetes mellitus (with fasting glucose levels above 200mg/dl)
  • Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years
  • Patients with a known history of HIV seropositivity
  • Active HCV infection (PCR + ; AST> 1.5-2x UN)
  • Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months.
  • Negative pregnancy test at baseline is required (serum β HCG).
  • Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment
  • Nodular lymphocyte prevalence histological subtype

Sites / Locations

  • UO Ematologia Casa Sollievo della Sofferenza
  • Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
  • Oncologia HSR Giglio
  • Oncologia Medica A Centro di Riferimento Oncologico
  • U.O. Oncoematologia Ospedale "Andrea Tortora"
  • UO Ematologia Ospedale San Donato
  • UO Ematologia con trapianto AOU Policlinico Consorziale
  • SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
  • Ematologia e CTMO Ospedale Businco
  • UOC Oncoematologia Garibaldi Nesima
  • UOC Ematologia Azienda Ospedaliera Cosenza
  • Unità Funzionale di Ematologia AOU Careggi
  • Ematologia- AOU San Martino IRCCS - IST
  • SC Medicina Trasfusionale ed Ematologia SS Ematologia ASLTO4
  • UO Ematologia PO Vito Fazzi
  • IRST Meldola
  • SC Ematologia AO Riuniti Papardo Piemonte
  • UO Oncoematologia AO San Carlo Borromeo Unità Semplice di Trapianto Midollo
  • Centro Oncoematologico Policlinico
  • Unità Complessa di Ematologia AO di Rilievo Nazionale A. Cardarelli
  • SCDU Ematologia Università Piemonte Orientale
  • Oncoematologia e TMO Dopartimento Oncologia La Maddalena
  • UO Complessa di Ematologia Ospedale di Parma
  • Clinica Ematologica Fondazione IRCCS Policlinico San Matteo
  • Ematologia Ospedale Santo Spirito
  • UO Ematologia Ospedale Santa Maria delle Croci
  • SC Ematologia Azienda Ospedaliera Arcispedale Santa Maria Nuova
  • UO Oncoematologia AUSL Rimini Ospedale Infermi
  • Ematologia e Trapianto Istituto Regina Elena IFO
  • Ematologia Ospedale Sant'Andrea
  • Ematologia Università La Sapienza
  • Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona
  • Azienda Ospedaliera Università Senese Clinica Ematologica Policlinico Le Scotte
  • Oncoematologia Università Perugia sede Terni
  • SC Ematologia AO Città della Salute e della Scienza
  • Clinica Ematologica AO S. Maria della Misericordia
  • UOC Ematologia Ospedale di Circolo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dose dense ABVD

Arm Description

1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)

Outcomes

Primary Outcome Measures

Feasibility
Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)
Activity
Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.

Secondary Outcome Measures

Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years
Concordance between pet results and patients prognosis
PFS
Progression free survival estimate (prognosis outcome)
OS
Overall survival estimate (prognosis outcome)
Toxicity
Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)
Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years
Concordance between pet results and patients prognosis

Full Information

First Posted
March 7, 2014
Last Updated
February 8, 2018
Sponsor
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT02247869
Brief Title
Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma
Official Title
Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
April 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Linfomi - ETS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma.
Detailed Description
Dose-density has been shown to be an important factor for complete remission rate and longterm survival in lymphomas. The aims of this study were to find out whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma. In view of emerging data on the role of early PET in defining prognosis in Hodgkin Lymphoma patients, the percentage of FDG-PET (fluorodeoxyglucose positron emission tomography) negativity after two cycle was chosen as the parameter to evaluate dd-ABVD activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
HL, Hodgkin Lymphoma, First line therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dose dense ABVD
Arm Type
Experimental
Arm Description
1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
Intervention Type
Drug
Intervention Name(s)
dose dense ABVD
Intervention Description
dose dense ABVD will be administered intravenously on day 1 and 8 every 21 days Chemotherapy regimen Doxorubicin 25 mg/m2 i.v. day 1 and 8 Bleomycin 10 mg/m2 i.v. day 1 and 8 Vinblastine 6 mg/m2 i.v. day 1 and 8 Dacarbazine 375 mg/m2 i.v. day 1 and 8 Granulocyte colony-stimulating factor (G-CSF): days 9 to 14
Primary Outcome Measure Information:
Title
Feasibility
Description
Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)
Time Frame
After 4 dd-ABVD cycles (12 weeks after starting treatment)
Title
Activity
Description
Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.
Time Frame
After 2 dd-ABVD cycles (6 week after starting treatment)
Secondary Outcome Measure Information:
Title
Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years
Description
Concordance between pet results and patients prognosis
Time Frame
After 3 years of follow-up
Title
PFS
Description
Progression free survival estimate (prognosis outcome)
Time Frame
2 years from the activation of therapy in the last patient enrolled onto the study.
Title
OS
Description
Overall survival estimate (prognosis outcome)
Time Frame
2 years from the activation of therapy in the last patient enrolled onto the study.
Title
Toxicity
Description
Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)
Time Frame
2 years from the activation of therapy in the last patient enrolled onto the study.
Title
Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years
Description
Concordance between pet results and patients prognosis
Time Frame
After 3 years of follow-up

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: Age 18-70 years Histologically confirmed Hodgkin Lymphoma stage I, II unfavorable according to EORTC (European Organisation for Research and Treatment of Cancer) criteria, with exclusion of stage II B bulky. Previously untreated ECOG (Eastern Cooperative Oncology Group) performance status 0 - 2 Staging with FDG-PET (fluorodeoxyglucose positron emission tomography) Written informed consent Adequate liver and renal function (total serum bilirubin < 2.5 x ULN, AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine < 2.5 x ULN) Exclusion Criteria: Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease. Uncontrolled diabetes mellitus (with fasting glucose levels above 200mg/dl) Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years Patients with a known history of HIV seropositivity Active HCV infection (PCR + ; AST> 1.5-2x UN) Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months. Negative pregnancy test at baseline is required (serum β HCG). Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment Nodular lymphocyte prevalence histological subtype
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, M.D.
Organizational Affiliation
Humanitas Cancer Center - Department of Medical Oncology and Haematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UO Ematologia Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
Country
Italy
Facility Name
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
Country
Italy
Facility Name
Oncologia HSR Giglio
City
Cefalù
State/Province
Palermo
Country
Italy
Facility Name
Oncologia Medica A Centro di Riferimento Oncologico
City
Aviano
State/Province
Pordenone
Country
Italy
Facility Name
U.O. Oncoematologia Ospedale "Andrea Tortora"
City
Pagani
State/Province
Salerno
Country
Italy
Facility Name
UO Ematologia Ospedale San Donato
City
Arezzo
Country
Italy
Facility Name
UO Ematologia con trapianto AOU Policlinico Consorziale
City
Bari
Country
Italy
Facility Name
SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
City
Biella
Country
Italy
Facility Name
Ematologia e CTMO Ospedale Businco
City
Cagliari
Country
Italy
Facility Name
UOC Oncoematologia Garibaldi Nesima
City
Catania
Country
Italy
Facility Name
UOC Ematologia Azienda Ospedaliera Cosenza
City
Cosenza
Country
Italy
Facility Name
Unità Funzionale di Ematologia AOU Careggi
City
Firenze
Country
Italy
Facility Name
Ematologia- AOU San Martino IRCCS - IST
City
Genova
Country
Italy
Facility Name
SC Medicina Trasfusionale ed Ematologia SS Ematologia ASLTO4
City
Ivrea
Country
Italy
Facility Name
UO Ematologia PO Vito Fazzi
City
Lecce
Country
Italy
Facility Name
IRST Meldola
City
Meldola
Country
Italy
Facility Name
SC Ematologia AO Riuniti Papardo Piemonte
City
Messina
Country
Italy
Facility Name
UO Oncoematologia AO San Carlo Borromeo Unità Semplice di Trapianto Midollo
City
Milano
Country
Italy
Facility Name
Centro Oncoematologico Policlinico
City
Modena
Country
Italy
Facility Name
Unità Complessa di Ematologia AO di Rilievo Nazionale A. Cardarelli
City
Napoli
Country
Italy
Facility Name
SCDU Ematologia Università Piemonte Orientale
City
Novara
Country
Italy
Facility Name
Oncoematologia e TMO Dopartimento Oncologia La Maddalena
City
Palermo
Country
Italy
Facility Name
UO Complessa di Ematologia Ospedale di Parma
City
Parma
Country
Italy
Facility Name
Clinica Ematologica Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Ematologia Ospedale Santo Spirito
City
Pescara
Country
Italy
Facility Name
UO Ematologia Ospedale Santa Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
SC Ematologia Azienda Ospedaliera Arcispedale Santa Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
UO Oncoematologia AUSL Rimini Ospedale Infermi
City
Rimini
Country
Italy
Facility Name
Ematologia e Trapianto Istituto Regina Elena IFO
City
Roma
Country
Italy
Facility Name
Ematologia Ospedale Sant'Andrea
City
Roma
Country
Italy
Facility Name
Ematologia Università La Sapienza
City
Roma
Country
Italy
Facility Name
Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona
City
Salerno
Country
Italy
Facility Name
Azienda Ospedaliera Università Senese Clinica Ematologica Policlinico Le Scotte
City
Siena
Country
Italy
Facility Name
Oncoematologia Università Perugia sede Terni
City
Terni
Country
Italy
Facility Name
SC Ematologia AO Città della Salute e della Scienza
City
Torino
Country
Italy
Facility Name
Clinica Ematologica AO S. Maria della Misericordia
City
Udine
Country
Italy
Facility Name
UOC Ematologia Ospedale di Circolo
City
Varese
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34327561
Citation
Santoro A, Mazza R, Spina M, Califano C, Specchia G, Carella M, Consoli U, Palombi F, Musso M, Pulsoni A, Kovalchuk S, Bonfichi M, Ricci F, Fabbri A, Liberati AM, Rodari M, Giordano L, Chimienti E, Balzarotti M, Sorasio R, Gallamini A, Ghiggi C, Ciammella P, Ricardi U, Chauvie S, Carlo-Stella C, Merli F. Dose-dense ABVD as first-line therapy in early-stage unfavorable Hodgkin lymphoma: results of a prospective, multicenter double-step phase II study by Fondazione Italiana Linfomi. Ann Hematol. 2021 Oct;100(10):2547-2556. doi: 10.1007/s00277-021-04604-x. Epub 2021 Jul 30.
Results Reference
derived

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Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma

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