NCT02556931

Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies

Phase II Study of Shortened-duration Tacrolimus Following Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Malignancies That Are Challenging to Engraft

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.

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. The experiences with immunosuppression duration with other allogeneic HSCT platforms cannot be directly extrapolated to the high-dose posttransplantation cyclophosphamide platform (another type of immunosuppressant given after transplant to help prevent GVHD). There are presently no published data on the minimum required duration of tacrolimus after nonmyeloablative HSCT that includes high-dose Cy as part of postgrafting immunosuppression. The effectiveness of high-dose posttransplantation Cy in GVHD prevention, however, permits the investigation of this question. At the present time there are few or no cures for diseases studied on this trial outside of a bone marrow or peripheral blood transplant. The peripheral blood for this transplant comes from a relative who is a half-match or "haplo" match to the participant. Possible donors include parents, siblings, and children. In order to help the bone marrow grow, or "take", inside the body, participants will receive chemotherapy and radiation before the transplant. After the transplant participants will receive high doses of cyclophosphamide (Cytoxan®) along with other medications to lower the immune system, such as tacrolimus. These medications may lower the risk of graft versus host disease (GVHD) and of rejection of the peripheral blood graft.

Conditions

• Myelodysplastic Syndrome
• Chronic Myelomonocytic Leukemia
• Small Lymphocytic Lymphoma
• Chronic Lymphocytic Leukemia
• Prolymphocytic Leukemia
• Chronic Myeloid Leukemia
• Chronic Myeloproliferative Disorders
• Multiple Myeloma
• Plasma Cell Neoplasm
• Plasma Cell Dyscrasia
• Myelofibrosis
• Polycythemia Vera
• Essential Thrombocythemia
• Plasma Cell Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine	Days -6 through -2: 30 mg/m\^2 IV daily
DRUG	Cyclophosphamide	Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily
RADIATION	Total body irradiation	Day -1: 200 cGy in a single fraction
DRUG	Tacrolimus	Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status.
DRUG	Mycophenolate mofetil	Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)

Timeline

• Start date: 2015-12-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2015-09-22
• Last updated: 2022-11-03
• Results posted: 2022-11-03

Locations

1 site across 1 country: United States