Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma
- Conditions
- Hodgkin Lymphoma
- Interventions
- Drug: dose dense ABVD
- Registration Number
- NCT02247869
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dose dense ABVD dose dense ABVD 1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
- Primary Outcome Measures
Name Time Method Feasibility After 4 dd-ABVD cycles (12 weeks after starting treatment) Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)
Activity After 2 dd-ABVD cycles (6 week after starting treatment) Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.
- Secondary Outcome Measures
Name Time Method Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years After 3 years of follow-up Concordance between pet results and patients prognosis
PFS 2 years from the activation of therapy in the last patient enrolled onto the study. Progression free survival estimate (prognosis outcome)
Toxicity 2 years from the activation of therapy in the last patient enrolled onto the study. Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)
OS 2 years from the activation of therapy in the last patient enrolled onto the study. Overall survival estimate (prognosis outcome)
Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years After 3 years of follow-up Concordance between pet results and patients prognosis
Trial Locations
- Locations (37)
Oncologia Medica A Centro di Riferimento Oncologico
🇮🇹Aviano, Pordenone, Italy
U.O. Oncoematologia Ospedale "Andrea Tortora"
🇮🇹Pagani, Salerno, Italy
UO Ematologia Ospedale San Donato
🇮🇹Arezzo, Italy
Ematologia e CTMO Ospedale Businco
🇮🇹Cagliari, Italy
UOC Oncoematologia Garibaldi Nesima
🇮🇹Catania, Italy
UOC Ematologia Azienda Ospedaliera Cosenza
🇮🇹Cosenza, Italy
UO Ematologia PO Vito Fazzi
🇮🇹Lecce, Italy
UO Oncoematologia AO San Carlo Borromeo Unità Semplice di Trapianto Midollo
🇮🇹Milano, Italy
Ematologia Università La Sapienza
🇮🇹Roma, Italy
Ematologia Ospedale Santo Spirito
🇮🇹Pescara, Italy
SC Ematologia Azienda Ospedaliera Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
UOC Ematologia Ospedale di Circolo
🇮🇹Varese, Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Ematologia- AOU San Martino IRCCS - IST
🇮🇹Genova, Italy
IRST Meldola
🇮🇹Meldola, Italy
Oncologia HSR Giglio
🇮🇹Cefalù, Palermo, Italy
UO Ematologia con trapianto AOU Policlinico Consorziale
🇮🇹Bari, Italy
UO Ematologia Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
SC Ematologia AO Riuniti Papardo Piemonte
🇮🇹Messina, Italy
Ematologia e Trapianto Istituto Regina Elena IFO
🇮🇹Roma, Italy
Ematologia Ospedale Sant'Andrea
🇮🇹Roma, Italy
SC Medicina Trasfusionale ed Ematologia SS Ematologia ASLTO4
🇮🇹Ivrea, Italy
UO Complessa di Ematologia Ospedale di Parma
🇮🇹Parma, Italy
UO Ematologia Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona
🇮🇹Salerno, Italy
Oncoematologia Università Perugia sede Terni
🇮🇹Terni, Italy
SCDU Ematologia Università Piemonte Orientale
🇮🇹Novara, Italy
SC Ematologia AO Città della Salute e della Scienza
🇮🇹Torino, Italy
UO Oncoematologia AUSL Rimini Ospedale Infermi
🇮🇹Rimini, Italy
Azienda Ospedaliera Università Senese Clinica Ematologica Policlinico Le Scotte
🇮🇹Siena, Italy
Clinica Ematologica AO S. Maria della Misericordia
🇮🇹Udine, Italy
SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
🇮🇹Biella, Italy
Unità Funzionale di Ematologia AOU Careggi
🇮🇹Firenze, Italy
Centro Oncoematologico Policlinico
🇮🇹Modena, Italy
Clinica Ematologica Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Unità Complessa di Ematologia AO di Rilievo Nazionale A. Cardarelli
🇮🇹Napoli, Italy
Oncoematologia e TMO Dopartimento Oncologia La Maddalena
🇮🇹Palermo, Italy