Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide
Condition: Hodgkin's Lymphoma; Leukemia; Myelodysplastic Syndrome(MDS); Multiple Myeloma; Non Hodgkin's Lymphoma
MeSH terms: Lymphoma; Multiple Myeloma; Preleukemia; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done to learn more about nonmyeloablative bone marrow transplantation
      (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow
      from a relative.
    

Detailed description: 
      The main goal is to learn whether a drug called tacrolimus, which is an immune-lowering drug
      (an immunosuppressant) given after transplant to help prevent certain complications, can be
      given safely for a shorter period of time than it has been in the past.

      At the present time there are few or no cures for your type of disease outside of a bone
      marrow transplant. The bone marrow for this transplant comes from a relative who is a
      half-match or "haplo" match to you. Possible donors include parents, siblings, and children.
      In order to help the bone marrow grow, or "take", inside your body, you will receive
      chemotherapy and radiation before the transplant. After the transplant you will receive high
      doses of cyclophosphamide (Cytoxan®) along with other medications to lower the immune system,
      tacrolimus. These medications may lower the risk of graft versus host disease (GVHD) and of
      your body rejecting the bone marrow graft.
    

Intervention name(s): Cyclophosphamide; Fludarabine; Total body irradiation; Mycophenolate Mofetil; Tacrolimus 60; Tacrolimus 90; Tacrolimus 120; Bone marrow transplant
Intervention type(s): Drug; Drug; Radiation; Drug; Drug; Drug; Drug; Biological
Intervention description(s): Days -6 and -5: 14.5 mg/kg/day IV. Days 3 and 4: 50 mg/kg/day IV.; Days -6, -5, -4, -3, and -2: 30 mg/m^2/day IV.; Day -1: 200 centigray in one fraction.; Days 5 to 35: 15 mg/kg PO three times per day; max daily dose 1 g.; Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 60.; Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 90.; Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 120.; Donor stem cells infused IV on Day 0.
Other intervention name(s): Cytoxan; Fludara; TBI; MMF; CellCept; FK-506; Prograf; FK-506; Prograf; FK-506; Prograf; BMT
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Fludarabine; Tacrolimus
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants were initially enrolled on the 90-day arm. When that arm completed enrollment, participants were enrolled on the 120-day arm while safety of the 90-day arm was evaluated. The 90-day arm was found to be safe, so participants were then enrolled on the 60-day arm for the remainder of the study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonmyeloablative; Allogeneic; Bone Marrow Transplant (BMT); Tacrolimus; Cyclophosphamide