NCT00568633

Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML

A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.

Conditions

• Leukemia, Myeloid
• Leukemia
• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
PROCEDURE	Allogeneic HSCT	Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \< 7 x 10e8 CD3+ cells/kg.
DRUG	Anti-thymocyte globulin (ATG)	1.5 mg/kg for 5 days by IV
DRUG	Cyclosporine (CSP)	6.25 mg/kg twice daily oral
DRUG	Mycophenolate mofetil (MMF)	15 mg/kg twice daily oral
RADIATION	Total lymphoid irradiation (TLI)	80 cGy/fraction radiotherapy in 10 fractions.
DRUG	Methylprednisolone sodium succinate	1.0 mg/kg for 5 days by IV
DRUG	Best standard care	Intervention consist of: * Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation) * Autologous transplantation * Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning * Umbilical cord blood transplantation * Haploidentical transplantation

Timeline

• Start date: 2007-08-01
• Primary completion: 2015-12-31
• Completion: 2015-12-31
• First posted: 2007-12-06
• Last updated: 2019-09-24
• Results posted: 2019-09-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study