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

Phase 2

Completed

• 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-25
• Primary Completion: 2015-06
• Study Completion: 2017-04-29
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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)

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

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