Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma
Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study
1 other identifier
interventional
100
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2012
Longer than P75 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 7, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2017
CompletedFebruary 9, 2018
February 1, 2018
3.3 years
March 7, 2014
February 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility
Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)
After 4 dd-ABVD cycles (12 weeks after starting treatment)
Activity
Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.
After 2 dd-ABVD cycles (6 week after starting treatment)
Secondary Outcomes (5)
Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years
After 3 years of follow-up
PFS
2 years from the activation of therapy in the last patient enrolled onto the study.
OS
2 years from the activation of therapy in the last patient enrolled onto the study.
Toxicity
2 years from the activation of therapy in the last patient enrolled onto the study.
Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years
After 3 years of follow-up
Study Arms (1)
dose dense ABVD
EXPERIMENTAL1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
Interventions
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
Eligibility Criteria
You may qualify if:
- Age 18-70 years
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
UO Ematologia Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
Rozzano, Milano, Italy
Oncologia HSR Giglio
Cefalù, Palermo, Italy
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
UO Ematologia con trapianto AOU Policlinico Consorziale
Bari, Italy
SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
Biella, Italy
Ematologia e CTMO Ospedale Businco
Cagliari, Italy
UOC Oncoematologia Garibaldi Nesima
Catania, Italy
UOC Ematologia Azienda Ospedaliera Cosenza
Cosenza, Italy
Unità Funzionale di Ematologia AOU Careggi
Florence, Italy
Ematologia- AOU San Martino IRCCS - IST
Genova, Italy
SC Medicina Trasfusionale ed Ematologia SS Ematologia ASLTO4
Ivrea, Italy
UO Ematologia PO Vito Fazzi
Lecce, Italy
IRST Meldola
Meldola, Italy
SC Ematologia AO Riuniti Papardo Piemonte
Messina, Italy
UO Oncoematologia AO San Carlo Borromeo Unità Semplice di Trapianto Midollo
Milan, Italy
Centro Oncoematologico Policlinico
Modena, Italy
Unità Complessa di Ematologia AO di Rilievo Nazionale A. Cardarelli
Napoli, Italy
SCDU Ematologia Università Piemonte Orientale
Novara, Italy
Oncoematologia e TMO Dopartimento Oncologia La Maddalena
Palermo, Italy
UO Complessa di Ematologia Ospedale di Parma
Parma, Italy
Clinica Ematologica Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Ematologia Ospedale Santo Spirito
Pescara, Italy
UO Ematologia Ospedale Santa Maria delle Croci
Ravenna, Italy
SC Ematologia Azienda Ospedaliera Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
UO Oncoematologia AUSL Rimini Ospedale Infermi
Rimini, Italy
Ematologia e Trapianto Istituto Regina Elena IFO
Roma, Italy
Ematologia Ospedale Sant'Andrea
Roma, Italy
Ematologia Università La Sapienza
Roma, Italy
Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona
Salerno, Italy
Azienda Ospedaliera Università Senese Clinica Ematologica Policlinico Le Scotte
Siena, Italy
Oncoematologia Università Perugia sede Terni
Terni, Italy
SC Ematologia AO Città della Salute e della Scienza
Torino, Italy
Clinica Ematologica AO S. Maria della Misericordia
Udine, Italy
UOC Ematologia Ospedale di Circolo
Varese, Italy
Related Publications (1)
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.
PMID: 34327561DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armando Santoro, M.D.
Humanitas Cancer Center - Department of Medical Oncology and Haematology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2014
First Posted
September 25, 2014
Study Start
February 1, 2012
Primary Completion
June 1, 2015
Study Completion
April 29, 2017
Last Updated
February 9, 2018
Record last verified: 2018-02