NCT00416884

Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML

Fludarabine, Campath, TBI T-Cell Deplete NMSCT With Post-Transplant T-Cell Infusions for CML Failing Imatinib Therapy With Imatinib (STI571)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 4 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T lymphocyte cells(T cells) from the donor cells before transplant, may stop this from happening. PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and total-body irradiation together with donor stem cell transplant and donor white blood cell (WBC) infusion works in treating patients with chronic phase chronic myelogenous leukemia (CML) that did not respond to previous imatinib mesylate.

Detailed description

OBJECTIVES: * Determine the treatment-related mortality in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia treated with nonmyeloablative conditioning comprising fludarabine, alemtuzumab, and total-body irradiation followed by T-cell-depleted allogeneic stem cell transplantation and post-transplantation allogeneic T-cell infusion. * Determine if donor engraftment can be safely established using partial T-cell depletion with additional T-cell infusions in these patients. OUTLINE: Patients receive alemtuzumab IV over 5-6 hours on day -8 and fludarabine IV on days -4 to -2. Patients undergo total-body irradiation followed by T-cell-depleted (CD34+ selected) allogeneic stem cell transplantation on day 0. Patients receive allogeneic T-cell infusion on days 30 and 60. Patients also receive cyclosporine twice daily beginning on day -3 and continuing until day 100 followed by a taper until day 177. PROJECTED ACCRUAL: Not specified.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	Campath	30 mg on day -8 over 5-6 hours
DRUG	Fludarabine	Fludarabine 30 mg/m\^2 on day -4 through day -2
RADIATION	Total Body Irradiation (TBI)	Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0
OTHER	T-Cell Deplete	Stem cells will be T cell depleted and given on day 0

Timeline

• Start date: 2003-05-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-12-28
• Last updated: 2017-09-27
• Results posted: 2011-08-02

Locations

1 site across 1 country: United States