NCT02178683

Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression

Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched or Mis-Matched Family or Unrelated Donor HCT

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Colorado Blood Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This protocol will evaluate Tacrolimus and MMF after conditioning with fludarabine and low-dose TBI in patients who are not candidates for conventional allografting. A novel approach to immunosuppression will be tested incorporating an early but extended taper of Tacrolimus starting on day +80 or in the case of relapse. The goal is to induce early immunity and GVT effects without compromising GVHD control. The anti-metabolite MMF will be re-introduced on day +100 to try and induce tolerance and block chronic GVHD during the taper of the Tacrolimus. DLI may be given in the presence of disease progression but not for mixed chimerism as in previous protocols.

Detailed description

OBJECTIVES Major Objectives A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from an HLA-Identical or non-identical family donor or unrelated donors, with fludarabine and low-dose TBI, with immunosuppression utilizing tacrolimus and MMF. B. To evaluate the incidence of grade II-IV GVHD associated with this treatment. C. To evaluate the engraftment when donors who are not HLA-identical family members are utilized for allogeneic stem cell transplantation. D. To evaluate the incidence of GVHD using three times per day MMF after unrelated donor stem cell transplants or two times per day MMF after family donor stem cell transplant. Minor Objectives A. To evaluate the incidence of chronic GVHD utilizing Tac/MMF with peripheral blood stem cells from matched or mis-matched allogeneic donors. B. To evaluate disease responses and survival after Flu/TBI allogeneic SCT.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Tacrolimus and MMF.	First dose of Tacrolimus is given day -4, this continues through day +365. First dose of MMF is given within 4 hours of stem cell infusion, this continues through day +365.

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-12-01
• Completion: 2018-12-01
• First posted: 2014-07-01
• Last updated: 2014-07-01

Locations

1 site across 1 country: United States