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

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ClinicalTrials.gov Identifier: NCT02247869
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: dose dense ABVD Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study
Study Start Date : February 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : April 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dose dense ABVD
1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
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





Primary Outcome Measures :
  1. Feasibility [ Time Frame: After 4 dd-ABVD cycles (12 weeks after starting treatment) ]
    Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)

  2. Activity [ Time Frame: 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 :
  1. Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years [ Time Frame: After 3 years of follow-up ]
    Concordance between pet results and patients prognosis

  2. PFS [ Time Frame: 2 years from the activation of therapy in the last patient enrolled onto the study. ]
    Progression free survival estimate (prognosis outcome)

  3. OS [ Time Frame: 2 years from the activation of therapy in the last patient enrolled onto the study. ]
    Overall survival estimate (prognosis outcome)

  4. Toxicity [ Time Frame: 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)

  5. Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years [ Time Frame: After 3 years of follow-up ]
    Concordance between pet results and patients prognosis



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247869


Locations
Italy
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
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
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
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
Principal Investigator: Armando Santoro, M.D. Humanitas Cancer Center - Department of Medical Oncology and Haematology

Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT02247869     History of Changes
Other Study ID Numbers: FIL - DDABVD
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by Fondazione Italiana Linfomi ONLUS:
HL
Hodgkin Lymphoma
First line therapy

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases