Allogenic Stem Cell Transplantation (SCT) With Non-Myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
Conditions
Non-Hodgkin Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
Allogeneic, Lymphoma, GELTAMO, Z-RIC
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: Ibritumomab Tiuxetan (Zevalin)
Type: Drug
Overall Status
Recruiting
Summary
To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Written informed consent

2. Histologically confirmed B-cell lymphoma of the following subtypes:

- LBCDL

- Grade 3b follicular lymphoma

- Mantle-cell lymphoma

- Transformed B-cell lymphoma

- Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant

3. High-risk B-cell CD20+ lymphoma defined by

- Having attained less than PR after two chemotherapy lines

- Post-transplantation relapse

- Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation

- Inability to collect enough stem cells for autologous transplantation

4. Stable disease at the time of transplantation

5. Age between 18 and 65

6. Performance status (ECOG) ≤ 2

7. Normal and suitable pulmonary function (DLCO ≥ 30%)

8. Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%

9. Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration)

Exclusion Criteria:

1. Prior treatment with radiopharmaceutical agents

2. HIV-associated lymphoma

3. Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)

4. Patient's inability to follow the protocol

5. Hypersensitivity to 90Y-itritumomab tiuxetan

6. Presence of severe pathologies that preclude chemotherapeutic treatment

7. Pregnant women or pregnancy risk due to inappropriate contraceptive measures

8. Breastfeeding women
Locations
H. Santa Creu i Sant Pau.
Barcelona, Barcelona., Spain
Status: Recruiting
Contact: Javier Briones, MD
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain
Status: Recruiting
Contact: José Rifón, 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 Princesa
Madrid, Spain
Status: Recruiting
Contact: Reyes Arranz, MD
H.U. Ramón y Cajal.
Madrid, Spain
Status: Recruiting
Contact: Jaime Perez de Oteyza, MD
H. Morales Meseguer.
Murcia, Spain
Status: Recruiting
Contact: Inmaculada Heras, MD
H. Virgen de la Arrixaca
Murcia, Spain
Status: Recruiting
Contact: Jose Moraleda, MD
H. Central de Asturias
Oviedo, Spain
Status: Recruiting
Contact: Teresa Bernal, MD
H. Clinico de Salamanca
Salamanca, Spain
Status: Recruiting
Contact: Dolores Caballero, MD - cabarri@usal.es
H. U. Marqués de Valdecilla.
Santander, Spain
Status: Recruiting
Contact: Eulogio Conde, MD
H. Clínico Valencia
Valencia, Spain
Status: Recruiting
Contact: Carlos Solano, MD
H. La Fe
Valencia, Spain
Status: Recruiting
Contact: Isidro Jarque, MD
H.U. Miguel Servet
Zaragoza., Spain
Status: Recruiting
Contact: Pilar Giraldo, MD
Start Date
November 2007
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