Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
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
The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP without transplant.
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
partial.
- 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).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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