Early Treatment Stratification Based on PET Scan Response to R-MEGACHOP Followed by R-MEGACHOP or R-IFE Plus Peripheral Autologous Stem Cell Transplant (PBSCT) in Patients With Poor Prognosis DLBCL
In addition to the above:
- To evaluate the overall survival after three years.
- To determine the rate of global responses and complete remissions, uncertain and
- To determine the duration of the complete response after the treatment termination.
- To carry out an exploratory follow up of the event free survival and the overall
survival at 5 years.
- To evaluate the treatment toxicity according CTC criteria (version 3.0) of the National
Cancer Institute (NCI).
- To asses the role of PET in the disease stage and response evaluation compared to CAT.
- To identify the predictable response factors after 6 cycles of treatment with
R-MegaCHOP administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH
in patients with DLBCL of severe prognosis.
- To evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment
and/or R-IFE in reference with delays with the cycles administration and reductions of
the chemotherapy dose (planned dose administrated in the planned term).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival at 3y in pat with DLBCL with a-IPI>1 or a-IPI=1 and ß2 µglobulin>=3mg/dl in pat PET+ after 3cycles of R-MegaCHOP and early rescue with R-IFE+TAPH or in pat PET- after 3cycles R-MegaCHOP followed by 3cycles of R-MegaCHOP without TAPH
5 years follow-up
José Fuster, MD
Son Dureta Hospital
Spain: Spanish Agency of Medicines