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

Hodgkin Lymphoma Clinical Trial

Official title:

Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247869
• Other study ID #: FIL - DDABVD
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2014
• Last updated: February 8, 2018
• Start date: February 2012
• Est. completion date: April 29, 2017

Study information

• Verified date: February 2018
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 29, 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• dose dense ABVD
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

Locations

Country	Name	City	State
Italy	UO Ematologia Ospedale San Donato	Arezzo
Italy	Oncologia Medica A Centro di Riferimento Oncologico	Aviano	Pordenone
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	Oncologia HSR Giglio	Cefalù	Palermo
Italy	UOC Ematologia Azienda Ospedaliera Cosenza	Cosenza
Italy	Unità Funzionale di Ematologia AOU Careggi	Firenze
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	Milano
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	U.O. Oncoematologia Ospedale "Andrea Tortora"	Pagani	Salerno
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	Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas	Rozzano	Milano
Italy	Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona	Salerno
Italy	UO Ematologia Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years	Concordance between pet results and patients prognosis	After 3 years of follow-up
Secondary	PFS	Progression free survival estimate (prognosis outcome)	2 years from the activation of therapy in the last patient enrolled onto the study.
Secondary	OS	Overall survival estimate (prognosis outcome)	2 years from the activation of therapy in the last patient enrolled onto the study.
Secondary	Toxicity	Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)	2 years from the activation of therapy in the last patient enrolled onto the study.
Secondary	Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years	Concordance between pet results and patients prognosis	After 3 years of follow-up