NCT00167180

Post Transplant Donor Lymphocyte Infusion

Use of Cyclophosphamide/Fludarabine to Promote in Vivo Expansion of Donor Lymphocyte Infusions (DLI) to Enhance Efficacy After Allogeneic Transplant

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the hypothesis that a pre-infusion preparative regimen of cyclophosphamide and fludarabine will improve the effectiveness of DLI in patients with blood cancers.

Detailed description

When cancer relapses after donor bone marrow transplantation, regular dose chemotherapy offers little hope of prolonged survival. However, there is evidence that lymphocytes can attack cancer cells. There is considerable evidence that this immune attack on cancer cells is associated with graft-versus-host disease. Although graft-versus-host disease can cause problems, this immune reaction may, in part, be the way that bone marrow transplantation cures cancer. In this study we hope that infusion of immune cells from the subject's bone marrow donor plus a chemotherapy regimen of cyclophosphamide and fludarabine will activate the subject's immune system to attack their cancer.

Conditions

• Leukemia, Myeloid, Chronic
• Lymphomas
• Multiple Myeloma
• Myelodysplastic Syndrome
• Leukemia, Lymphocytic, Acute
• Leukemia, Lymphocytic, Chronic
• AML

Interventions

Type	Name	Description
PROCEDURE	Donor Lymphocyte Infusion	donor cells infused over 2 hrs at cell dose of 0.5 dx 10\^8 CD3+T-cells/kg
DRUG	Induction Chemotherapy	Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV

Timeline

• Start date: 2004-01-01
• Primary completion: 2017-11-21
• Completion: 2018-12-24
• First posted: 2005-09-14
• Last updated: 2019-07-30
• Results posted: 2017-07-11

Locations

1 site across 1 country: United States