Swog S0410/Bmt Ctn 0703: A Phase Ii Trial Of Tandem Autologous Stem Cell Transplantation (Ahct) For Patients With Primary Progressive Or Recurrent Hodgkin Lymphoma (Hl) (Clinicaltrials.Gov Identifier: Nct00233987)

Background: The SWOG 9011 trial of augmented conditioning regimens (12 Gy TBI or BCNU 15mg/kg with both etoposide 60 mg/kg and cyclophosphamide 100 mg/kg) prior to single AHCT for pts with relapsed or refractory HL demonstrated 5-yr PFS and OS of 41% and 54% respectively in 74 treated pts. Among 46 previously irradiated pts with 2-3 high risk features, the 5-yr OS was 38% compared with 60% for pts with 0-1 risk features. Post-AHCT relapse was the major cause of failure (Stiff et al. BBMT 2003; 9:529). The strategy of sequential high-dose (HD) chemotherapy + tandem AHCT for poor prognosis HL patients was investigated in a City of Hope (COH) & Loyola University (LU) pilot trial of tandem AHCT in 46 HL pts with primary progressive or relapsed HL with at least 1 poor-risk feature. Trial results were promising, with 5-yr OS, EFS and FFP of 54%, 49% and 55% respectively and 100-day TRM of 4% (Fung et al. BBMT 2007;13:594). The purpose of the SWOG led trial S0410 was to evaluate the COH/LU regimen in a phase II cooperative group setting, with the primary endpoint of 2-yr PFS.