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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Colorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGEngraftment
To measure safe, stable engraftment using Tacrolimus and Mycophenolate Mofetil as post-grafting immunosuppression in patients following conditioning with fludarabine and total-body irradiation for allogeneic stem cell transplant.
Time frame: Post 100 days
Graft Versus Host Disease
To measure the incidence of grade II-IV GVHD associated with Tacrolimus and Mycophenolate Mofetil as post-grafting immunosuppression.
Time frame: Post 100 days
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