Clinical Trials Directory

Trials / Completed

CompletedNCT00027820

Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer

Low-Dose TBI and Fludarabine Followed by Nonmyeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation Using Enhanced Postgrafting Immunosuppression for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
106 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work. Researchers are hoping to see a mixture of recipient and donor stem cells after transplant. This mixture of donor and recipient stem cells is called "mixed-chimerism". Researchers hope to see these donor cells eliminate tumor cells. This is called a "graft-versus-leukemia" response.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether stable unrelated peripheral blood stem cell (PBSC) grafts can be safely established using nonmyeloablative pretransplant conditioning with intensified post-grafting immunosuppression and with every (q) 8 hours (hr) and possibly q 6 hr mycophenolate mofetil (MMF) dosing in patients with hematologic malignancies and renal cell carcinoma. II. To determine if the incidence and severity of acute grades II-IV graft-versus-host disease (GVHD) can be reduced in patients with sustained engraftment with the use of q 8 hr MMF dosing. SECONDARY OBJECTIVES: I. To determine if engraftment can be maintained in patients with low chimerism and high risk of rejection with the use of a single dose of fludarabine (fludarabine phosphate) followed by donor lymphocyte infusion (DLI) on continued MMF/cyclosporine (CSP). II. To compare survival and disease free survival to those achieved under protocol 1463. OUTLINE: REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) on days -4, -3, and -2 and undergo total-body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO every 8 hours on days 0-40 with taper to day 96. After completion of study treatment, patients are followed up at 6 months, 1 year, 1.5 years, 2 years, and then annually thereafter.

Conditions

Interventions

TypeNameDescription
DRUGFludarabine PhosphateGiven IV
RADIATIONTotal-Body IrradiationUndergo TBI
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo nonmyeloablative PBSCT
PROCEDURENonmyeloablative Allogeneic Hematopoietic Stem Cell TransplantationUndergo nonmyeloablative PBSCT
DRUGCyclosporineGiven PO
DRUGMycophenolate MofetilGiven PO

Timeline

Start date
2001-08-01
Primary completion
2004-09-01
Completion
2004-09-05
First posted
2003-01-27
Last updated
2019-12-20

Locations

10 sites across 3 countries: United States, Germany, Italy

Source: ClinicalTrials.gov record NCT00027820. Inclusion in this directory is not an endorsement.