Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatment dose dense abvd
Phase phase 2
Sponsor Fondazione Italiana Linfomi ONLUS
Start date February 2012
End date June 2015
Trial size 100 participants
Trial identifier NCT02247869, FIL - DDABVD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
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 Outcomes

Measure
Feasibility
time frame: After 4 dd-ABVD cycles (12 weeks after starting treatment)
Activity
time frame: After 2 dd-ABVD cycles (6 week after starting treatment)

Secondary Outcomes

Measure
Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years
time frame: After 3 years of follow-up
PFS
time frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
OS
time frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
Toxicity
time frame: 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
time frame: After 3 years of follow-up

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study
Principal investigator Armando Santoro, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Fondazione Italiana Linfomi ONLUS.