TheranosticTrials.org

Clinical Trial · NCT00646750

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

Overview

To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Dolores Caballero, MD (PRINCIPAL_INVESTIGATOR)

Javier Briones, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00646750

Eligibility

Inclusion

  • Patients with transformed lymphoma, on first partial remission (No CR).
  • Abide by at least one of the following conditions:
  • FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
  • Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
  • Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else
  • 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.:
  • HIV negative.
  • Performance status (ECOG) \< 3.
  • Creatinine \< 2 times the maximum normal value, and creatinine clearance \> 40 ml/min, except if attributable to the underlying disease.
  • Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like.
  • Total bilirubin and transaminases \< 3 times the normal maximum value, except if attributable to the underlying disease.
  • Patients on first recidivation who do not attain partial remission after salvage chemotherapy.
  • Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.
  • Stable disease at the time of transplantation.

Exclusion

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