NCT01220297

Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT

Sirolimus and Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)

Detailed description

To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft-vs-host disease (GvHD) prevention in human leukocyte antigen (HLA)-matched related donor peripheral blood stem cell (PBSC) or marrow transplantation (BMT), collectively hematopoietic stem cell transplantation (HSCT). This study will report the toxicities associated with this drug combination. For all treatments and procedures, Study Day is based on the day of HSCT as Day 0.

Conditions

• Hematologic Diseases
• Acute-graft-versus-host Disease
• Leukemia
• Non-Hodgkin Lymphoma (NHL)
• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Sirolimus	Immunosuppressant administered orally to: * Adults (age 14 and older), beginning on Day -3 with 12 mg loading dose, followed by 4 mg/day. * Children \< 13 years or weighing 40 kg, beginning on Day -3 with 3 mg/m² loading dose, followed by 1 mg/ m², rounded to the nearest full milligram. Daily dosage may be adjusted to maintain a target serum trough level of 3 to 12 ng/ml. Sirolimus dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.
DRUG	Mycophenolate mofetil (MMF)	Immunosuppressant given intravenously (IV) at 15 mg/kg 3 times daily, starting on Day 0 ≥ 2 hr after the completion of the HSCT infusion. Dose of MMF will be based on actual body weight, but limited to 15 kg above ideal body weight. MMF dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.
DRUG	Carmustine	For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -6 at the lesser of 15 mg/kg or 550 mg/m².
DRUG	Etoposide	For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -4 at 60 mg/kg
DRUG	Cyclophosphamide (Cyclo, CY)	Cyclophosphamide is a chemotherapy agent. For FTBI + Cyclophosphamide cohort, administered IV on Day -3 and -2 at 60 mg/kg. For Carmustine + Etoposide + Cyclophosphamide cohort, administered IV on Day -2 at 100 mg/kg
DRUG	FTBI	For FTBI + Cyclophosphamide cohort, administered as 1320 cGy delivered in 11 120 cGy fractions over 4 days starting on Day -7.

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-08-01
• Completion: 2011-08-01
• First posted: 2010-10-13
• Last updated: 2017-06-05
• Results posted: 2017-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study