Trials / Completed

CompletedNCT00060424

Fludarabine Phosphate and Total-Body Irradiation Before Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia

Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning for Patients With Chronic Lymphocytic Leukemia - A Multi-center Trial

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 21 (actual)

Sponsor: Fred Hutchinson Cancer Center · Academic / Other
Sex: All
Age: 21 Years
Healthy volunteers: Not accepted

Summary

This clinical trial studies how well giving fludarabine phosphate together with total-body irradiation (TBI) before donor peripheral blood stem cell transplant works in treating patients with chronic lymphocytic leukemia or small lymphocytic leukemia. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy before or after peripheral blood stem cell transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether nonmyeloablative allogeneic hematopoietic stem cell transplantation (HSCT) from matched-related donors can improve the probability of survival 18 months after treatment for fludarabine (fludarabine phosphate)-refractory, fludarabine phosphate, cyclophosphamide, and rituximab (FCR)-failed, or del 17p chronic lymphocytic leukemia (CLL) beyond that observed in historical controls (30%). SECONDARY OBJECTIVES: I. To assess the rate of relapse with allogeneic HSCT using nonmyeloablative conditioning for patients with fludarabine-refractory, FCR-failed, or del 17p CLL compared with historical data on autologous HSCT. II. To estimate the incidence of grade 2-4 acute graft-versus-host disease (GVHD) and chronic GVHD in patients with CLL treated with low-dose TBI, fludarabine, peripheral blood stem cell (PBSC) infusion and immunosuppression with cyclosporine and mycophenolate mofetil. III. To characterize the rate and types of infections with this regimen. IV. To estimate the rate of transplant-related mortality in the first 200 days. OUTLINE: NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine orally (PO) every 12 hours on days -3 to 180 with taper beginning on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27. After completion of study treatment, patients are followed up at 12 and 18 months and then annually for 5 years.

Conditions

Interventions

Type	Name	Description
DRUG	Cyclosporine	Given PO
DRUG	Fludarabine Phosphate	Given IV
PROCEDURE	Hematopoietic Cell Transplantation	Undergo allogeneic peripheral blood stem cell transplant
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Mycophenolate Mofetil	Given PO
PROCEDURE	Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation	Undergo allogeneic peripheral blood stem cell transplant
RADIATION	Total-Body Irradiation	Undergo TBI

Timeline

Start date: 2003-03-01
Primary completion: 2010-09-01
Completion: 2010-09-22
First posted: 2003-05-07
Last updated: 2017-12-08
Results posted: 2017-12-08

Locations

3 sites across 2 countries: United States, Italy

Source: ClinicalTrials.gov record NCT00060424. Inclusion in this directory is not an endorsement.