NCT02248597

Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases

Haploidentical Stem Cell Transplant Using Post Transplant Cyclophosphamide for GvHD Prophylaxis: A Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (DFS) at 12 months at our institution. SECONDARY OBJECTIVES: I. To determine the rate of acute and chronic graft-versus-host disease (GvHD), non-relapse mortality, and relapse. OUTLINE: PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) once daily (QD) on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2 TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. After completion of study treatment, patients are followed up periodically for 2 years.

Conditions

• Graft Versus Host Disease
• Hematopoietic/Lymphoid Cancer

Interventions

Type	Name	Description
DRUG	fludarabine phosphate	Given IV
DRUG	busulfan	Given IV
DRUG	cyclophosphamide	Given IV
PROCEDURE	allogeneic hematopoietic stem cell transplantation	Undergo myeloablative or reduced intensity allogeneic stem cell transplant
DRUG	tacrolimus
DRUG	mycophenolate mofetil

Timeline

• Start date: 2015-02-25
• Primary completion: 2022-01-18
• Completion: 2023-01-18
• First posted: 2014-09-25
• Last updated: 2023-10-11
• Results posted: 2023-10-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study