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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
* If PET + after third cycle: 2 cycles of R-IFE followed by PBSCT * If PET - after third cycle: 3 additional cycles of R-MegaCHOP - R-MegaCHOP: cycles every 21 days RITUXIMAB Dosage: 375mg/m2, IV, day 1 CICLOPHOSPHAMIDE Dosage: 1500 mg/m2, IV, day 1 DOXORUBICIN Dosage: 65 mg/m2, IV, day 1 VINCRISTIN: Dosage 1.4 mg/m2 (max. 2.0 mg/m2, IV, day 1 PREDNISONE Dosage: 60 mg/m2, IV, day 1-5 R-IFE: 2 cycles every 21 days: IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3. ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3).
ICO- Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
Hospital Clínico Univ. de Santiago
Santiago de Compostela, Galicia, Spain
Complejo Hospitalario de Jaén
Jaén, Jaén, Spain
Hospital Universitario La Princesa
Madrid, Madrid, Spain
Hospital Universitario Gregorio Marañon
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Univ. Son Dureta
Palma de Mallorca, Mallorca, Spain
...and 9 more locations
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
Time frame: 5 years follow-up
To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.
Time frame: 5 years follow-up
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