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

NCT ID: NCT02247869

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-04-29

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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dose dense ABVD

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

Group Type: EXPERIMENTAL

dose dense ABVD

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armando Santoro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Humanitas Cancer Center - Department of Medical Oncology and Haematology

Locations

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

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 34327561 (View on PubMed)

Other Identifiers

FIL - DDABVD

Identifier Type: -

Identifier Source: org_study_id