Clinical trial NCT02247869: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: HL
Hodgkin Lymphoma
First line therapy
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility
timeFrame: After 4 dd-ABVD cycles (12 weeks after starting treatment)
measure: Activity
timeFrame: After 2 dd-ABVD cycles (6 week after starting treatment)
Secondary outcomes:
measure: Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years
timeFrame: After 3 years of follow-up
measure: PFS
timeFrame: 2 years from the activation of therapy in the last patient enrolled onto the study.
measure: OS
timeFrame: 2 years from the activation of therapy in the last patient enrolled onto the study.
measure: Toxicity
timeFrame: 2 years from the activation of therapy in the last patient enrolled onto the study.
measure: Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years
timeFrame: After 3 years of follow-up
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: UO Ematologia Casa Sollievo della Sofferenza
state: Foggia
city: Rozzano
country: Italy
facility: Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
state: Milano
city: Cefalù
country: Italy
facility: Oncologia HSR Giglio
state: Palermo
city: Aviano
country: Italy
facility: Oncologia Medica A Centro di Riferimento Oncologico
state: Pordenone
city: Pagani
country: Italy
facility: U.O. Oncoematologia Ospedale "Andrea Tortora"
state: Salerno
city: Arezzo
country: Italy
facility: UO Ematologia Ospedale San Donato
city: Bari
country: Italy
facility: UO Ematologia con trapianto AOU Policlinico Consorziale
city: Biella
country: Italy
facility: SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
city: Cagliari
country: Italy
facility: Ematologia e CTMO Ospedale Businco
city: Catania
country: Italy
facility: UOC Oncoematologia Garibaldi Nesima
city: Cosenza
country: Italy
facility: UOC Ematologia Azienda Ospedaliera Cosenza
city: Firenze
country: Italy
facility: Unità Funzionale di Ematologia AOU Careggi
city: Genova
country: Italy
facility: Ematologia- AOU San Martino IRCCS - IST
city: Ivrea
country: Italy
facility: SC Medicina Trasfusionale ed Ematologia SS Ematologia ASLTO4
city: Lecce
country: Italy
facility: UO Ematologia PO Vito Fazzi
city: Meldola
country: Italy
facility: IRST Meldola
city: Messina
country: Italy
facility: SC Ematologia AO Riuniti Papardo Piemonte
city: Milano
country: Italy
facility: UO Oncoematologia AO San Carlo Borromeo Unità Semplice di Trapianto Midollo
city: Modena
country: Italy
facility: Centro Oncoematologico Policlinico
city: Napoli
country: Italy
facility: Unità Complessa di Ematologia AO di Rilievo Nazionale A. Cardarelli
city: Novara
country: Italy
facility: SCDU Ematologia Università Piemonte Orientale
city: Palermo
country: Italy
facility: Oncoematologia e TMO Dopartimento Oncologia La Maddalena
city: Parma
country: Italy
facility: UO Complessa di Ematologia Ospedale di Parma
city: Pavia
country: Italy
facility: Clinica Ematologica Fondazione IRCCS Policlinico San Matteo
city: Pescara
country: Italy
facility: Ematologia Ospedale Santo Spirito
city: Ravenna
country: Italy
facility: UO Ematologia Ospedale Santa Maria delle Croci
city: Reggio Emilia
country: Italy
facility: SC Ematologia Azienda Ospedaliera Arcispedale Santa Maria Nuova
city: Rimini
country: Italy
facility: UO Oncoematologia AUSL Rimini Ospedale Infermi
city: Roma
country: Italy
facility: Ematologia e Trapianto Istituto Regina Elena IFO
city: Roma
country: Italy
facility: Ematologia Ospedale Sant'Andrea
city: Roma
country: Italy
facility: Ematologia Università La Sapienza
city: Salerno
country: Italy
facility: Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona
city: Siena
country: Italy
facility: Azienda Ospedaliera Università Senese Clinica Ematologica Policlinico Le Scotte
city: Terni
country: Italy
facility: Oncoematologia Università Perugia sede Terni
city: Torino
country: Italy
facility: SC Ematologia AO Città della Salute e della Scienza
city: Udine
country: Italy
facility: Clinica Ematologica AO S. Maria della Misericordia
city: Varese
country: Italy
facility: UOC Ematologia Ospedale di Circolo
Study officials:
affiliation: Humanitas Cancer Center - Department of Medical Oncology and Haematology
name: Armando Santoro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.