A Phase 2/3 interventional study of ABVD and ABVD and Radiotherapy in Hodgkin's Lymphoma, sponsored by Fondazione Italiana Linfomi - ETS. Completed at 27 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Fondazione Italiana Linfomi - ETS · Phase 2/3, Interventional, and Treatment
The purpose of this study is to define an improvement in patients:
This study is composed by two phases:
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 520 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Fondazione Italiana Linfomi - ETS is the lead sponsor of 89 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: * PET-2 positive patients will be high-dose salvage treatment; * PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: * Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. * Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). PET-6 negative patients will be randomized to first arm: No radiotherapy.
Drug: ABVD
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: * PET-2 positive patients will be high-dose salvage treatment; * PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: * Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. * Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). PET-6 negative patients will be randomized to second arm: Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease.
Drug: ABVD and Radiotherapy
ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm A (Observation)
ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk).
To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue.
Time frame: 4 years
To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD.
Time frame: 4 years
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Fondazione Italiana Linfomi - ETS