NCT01342289

Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide

Shortened-duration Tacrolimus Following Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 6 Months – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin's Lymphoma
• Leukemia
• Myelodysplastic Syndrome(MDS)
• Multiple Myeloma
• Non Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Days -6 and -5: 14.5 mg/kg/day IV. Days 3 and 4: 50 mg/kg/day IV.
DRUG	Fludarabine	Days -6, -5, -4, -3, and -2: 30 mg/m\^2/day IV.
RADIATION	Total body irradiation	Day -1: 200 centigray in one fraction.
DRUG	Mycophenolate Mofetil	Days 5 to 35: 15 mg/kg PO three times per day; max daily dose 1 g.
DRUG	Tacrolimus 60	Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 60.
DRUG	Tacrolimus 90	Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 90.
DRUG	Tacrolimus 120	Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 120.
BIOLOGICAL	Bone marrow transplant	Donor stem cells infused IV on Day 0.

Timeline

• Start date: 2011-08-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2011-04-27
• Last updated: 2018-10-17

Locations

1 site across 1 country: United States