Status:
COMPLETED
Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom
Lead Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00646750
Start Date
January 1 2008
End Date
June 1 2012
Last Update
February 15 2016
Active Locations (18)
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1
Hospital Universitario de Alicante
Alicante, Alicante, Spain
2
H. de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
3
Instituto Catalán de Oncología,
Barcelona, Barcelona, Spain
4
H.Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain