NCT00807196

Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma

Phase I-II Non-Randomized Study of Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Indolent Non Hodgkin Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the ability to combine a radioactive medication directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem cell transplant.

Detailed description

Despite initial high response rates of low grade Non Hodgkin lymphoma, progressive or refractory disease currently remains incurable. Being a radiosensitive tumor, we hypothesize that combining different modalities of treatment including targeted radioimmunotherapy (RIT), and a graft versus lymphoma effect related to an allogeneic non myeloablative stem cell transplant may increase response and survival rates in a safe manner in patients with persistent disease following initial treatment. In this study patients who are not eligible for a standard stem cell transplant approach because of relapsed or refractory disease and who have a related sibling donor are treated with RIT followed by an allogeneic non myeloablative blood stem cell transplant

Conditions

• Non-Hodgkins Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	250mg/m2 day -21 and day -14 of preparative regimen
DRUG	90Y ibritumomab tiuxetan (Zevalin)	0.4 mCi/kg IV on day -14 of preparative regimen
DRUG	Cyclophosphamide	300mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
DRUG	Fludarabine	30mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
OTHER	Non myeloablative allogeneic stem cell transplantation	Blood stem cell infusion on day 0

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2008-12-11
• Last updated: 2008-12-11

Locations

1 site across 1 country: Canada