Clinical Trials Directory

Trials / Completed

CompletedNCT01427881

Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies

A Phase II Study to Evaluate the Efficacy of Posttransplant Cyclophosphamide for Prevention of Chronic Graft-versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
43 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well cyclophosphamide works in preventing chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before transplantation helps stop the growth of cancer cells and prevents the patient's immune system from rejecting the donor's stem cells. Healthy stem cells from a donor that are infused into the patient help the patient's bone marrow make blood cells; red blood cells, white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause an immune response against the body's normal cells, which is called graft-versus-host disease (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make chronic GVHD less severe.

Detailed description

PRIMARY OBJECTIVES: I. The primary objective of this study is to assess outcomes when high-dose cyclophosphamide (CY) is administered on days 3 and 4 followed by cyclosporine (CSP) after human leukocyte antigen (HLA)-matched related or unrelated mobilized blood cell transplantation with total-body irradiation (TBI) or busulfan (BU)-based conditioning. SECONDARY OBJECTIVES: I. The secondary objective of this study is to assess hematopoietic cell transplantation (HCT) outcomes when withdrawal of CSP is accelerated in patients without acute graft-versus-host disease (GVHD). OUTLINE: Patients' conditioning regimens are determined by the Clinical Coordinator after consultation with the attending physician. Based on disease, patients receive either TBI or fludarabine and busulfan. PREPARATIVE REGIMEN: Patients receive TBI twice daily (BID) on days -4 or -3 to -1. Some patients also receive fludarabine intravenously (IV) daily on days -5 to -2 and busulfan IV over 3 hours once daily (QD) or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo central nervous system (CNS) prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at day 180 and then annually for 5 years.

Conditions

Interventions

TypeNameDescription
DRUGcyclophosphamideGiven IV
DRUGcyclosporineGiven IV
PROCEDUREperipheral blood stem cell transplantationUndergo allogeneic PBSCT
RADIATIONtotal-body irradiationUndergo TBI
DRUGfludarabine phosphateGiven IV
DRUGbusulfanGiven IV
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo allogeneic PBSCT

Timeline

Start date
2011-09-01
Primary completion
2014-06-01
Completion
2015-07-01
First posted
2011-09-02
Last updated
2017-05-19
Results posted
2017-05-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01427881. Inclusion in this directory is not an endorsement.