NCT00644371

Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)

Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Ibritumomab Tiuxetan (Zevalin)	Conditioning Regimen 1. Rituximab, 250 mg/m2 on days -21 and -14. 2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14. Chemotherapy: * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion. Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months: * Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8. * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-02-21
• Completion: 2013-02-04
• First posted: 2008-03-26
• Last updated: 2017-03-27

Locations

14 sites across 1 country: Spain