Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-Cell Difusse Lymphom
Conditions
Non-Hodgkin's Lymphoma
Conditions: official terms
Lymphoma, Non-Hodgkin
Conditions: Keywords
Z-BEAM, Autologous, Lymphoma, GELTAMO
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
Type: Drug
Overall Status
Recruiting
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 autologous transplantation of peripheral blood haematopoietic stem cells.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Give their written informed consent.

2. 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).

3. Stable disease at the time of transplantation.

4. Age ≥ 18 but ≤ 70.

5. 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.:

1. Performance status (ECOG) < 3.

2. FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.

3. Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.

4. Total bilirubin and transaminases < 3 times the normal maximum value, except if attributable to the underlying disease.

5. Creatinine < 2 times the maximum normal value, and creatinine clearance > 40 ml/min, except if attributable to the underlying disease.

6. Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.

7. HIV negative.

Exclusion Criteria:

1. Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.

2. Known hypersensitivity to mouse proteins.

3. Involvement of CNS by lymphoma.

4. Progressive lymphoma during the month prior to the date of transplantation.

5. Previous radioimmunotherapy.

6. Previous autologous transplantation of haematopoietic stem cells.

7. Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method.

8. Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial.

9. Active psychiatric disease, including addiction disorders.

10. Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.
Locations
H.U. Central de Asturias, Oviedo
Oviedo, Asturias, Spain
Status: Recruiting
Contact: Teresa Bernal del Castillo, MD
H.Universitario de Canarias
Santa Cruz de Tenerife, Canarias, Spain
Status: Recruiting
Contact: Miguel Hernández, MD
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain
Status: Recruiting
Contact: Carlos Panizo, MD
Hospital Universitario de Alicante
Alicante, Spain
Status: Recruiting
Contact: Pascual Fernández, MD
H. de la Santa Creu i Sant Pau
Barcelona, Spain
Status: Recruiting
Contact: Javier Briones, MD
Instituto Catalán de Oncología,
Barcelona, Spain
Status: Recruiting
Contact: Eva González, MD
H. Reina Sofía
Córdoba, Spain
Status: Recruiting
Contact: Antonio Torres, MD
Clínica Puerta de Hierro,
Madrid, Spain
Status: Recruiting
Contact: José Antonio García-Marco, MD
H.U. 12 de Octubre,
Madrid, Spain
Status: Recruiting
Contact: Carlos Grande, MD
H.U. Gregorio Marañón,
Madrid, Spain
Status: Recruiting
Contact: Jorge Gayoso, MD
H.U. La Paz
Madrid, Spain
Status: Recruiting
Contact: Miguel Canales, MD
H.U. La Princesa
Madrid, Spain
Status: Recruiting
Contact: Reyes Arranz, MD
M.D. Anderson Internacional
Madrid, Spain
Status: Recruiting
Contact: José Francisco Tomás, MD
H. Morales Messeguer
Murcia, Spain
Status: Recruiting
Contact: Inmaculada Heras, MD
H.U. Virgen de la Arrixaca
Murcia, Spain
Status: Recruiting
Contact: José M Moraleda, MD
H. Clínico Universitario de Salamanca
Salamanca, Spain
Status: Recruiting
Contact: Dolores Caballero, MD
H.U. Marqués de Valdecilla
Santander, Spain
Status: Recruiting
Contact: Eulogio Conde, MD
H.U. La Fe
Valencia, Spain
Status: Recruiting
Contact: Isidro Jarque, MD
Start Date
January 2008
Sponsors
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Source
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page