Clinical Trials Directory

Trials / Completed

CompletedNCT00040846

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

Campath® [Alemtuzumab] Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class I Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies - A Multi-Center Trial

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

Summary

This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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 also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen (HLA)-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody (mAb) Campath (alemtuzumab) in patients with hematologic malignancies. SECONDARY OBJECTIVES: I. Evaluate the risk of occurrence of acute and chronic graft-vs-host disease (GVHD). II. Evaluate the risk/incidence of infections. III. Determine whether engraftment can be maintained with a single dose fludarabine, donor lymphocyte infusion (DLI) and continued MMF/CSP. IV. Evaluate the risk for disease progression and relapse. OUTLINE: This is a dose-escalation study of alemtuzumab. CONDITIONING REGIMEN: Patients receive alemtuzumab intravenously (IV) over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT): Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or orally (PO) twice daily (BID) on days -3 to 180 with taper to day 365 and MMF PO thrice daily (TID) on days 0-100 with taper to day 156. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

TypeNameDescription
BIOLOGICALalemtuzumabGiven IV
DRUGfludarabine phosphateGiven IV
RADIATIONtotal-body irradiationUndergo TBI
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo allogeneic HSCT
PROCEDUREperipheral blood stem cell transplantationUndergo allogeneic peripheral blood stem cell transplantation
DRUGmycophenolate mofetilGiven PO
DRUGcyclosporineGiven IV or PO

Timeline

Start date
2001-11-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2003-01-27
Last updated
2020-01-29
Results posted
2017-03-16

Locations

7 sites across 2 countries: United States, Italy

Source: ClinicalTrials.gov record NCT00040846. Inclusion in this directory is not an endorsement.