A Phase I/II Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation (Bu Flu TBI)

NCT00245037 Phase 1/Phase 2 COMPLETED Results posted

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood 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) 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 mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer.

Details

Lead sponsor	OHSU Knight Cancer Institute
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	147
Start date	2005-06
Completion	2015-08

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms
• Precancerous Condition

Interventions

• therapeutic allogeneic lymphocytes
• busulfan
• cyclosporine
• fludarabine phosphate
• mycophenolate mofetil
• peripheral blood stem cell transplantation
• Total Body Irradiation (TBI)
• Granulocyte colony-stimulating factor (G-CSF)
• Phenytoin
• Methotrexate

Primary outcomes

• Regimen-Related Toxicities — 5 years post-transplant
  Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.
• Non-relapse Mortality — Two years post-transplant
  Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease.

Countries

United States