Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom

Inclusion criteria

• Give their written informed consent.
• Abide by at least one of the following conditions:

• Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else
• Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like.
• Patients on first recidivation who do not attain partial remission after salvage chemotherapy.
• Patients with transformed lymphoma, on first partial remission (No CR).
• Stable disease at the time of transplantation.
• Age ≥ 18 but ≤ 70.
• Life expectancy of greater than three months.

Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:

• Performance status (ECOG) < 3.
• FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
• Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
• Total bilirubin and transaminases < 3 times the normal maximum value, except if attributable to the underlying disease.
• Creatinine < 2 times the maximum normal value, and creatinine clearance > 40 ml/min, except if attributable to the underlying disease.
• Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.
• HIV negative.

Exclusion criteria

• Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.
• Known hypersensitivity to mouse proteins.
• Involvement of CNS by lymphoma.
• Progressive lymphoma during the month prior to the date of transplantation.
• Previous radioimmunotherapy.
• Previous autologous transplantation of haematopoietic stem cells.
• Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method.
• Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial.
• Active psychiatric disease, including addiction disorders.
• Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.