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Clinical Trials/NCT00568633
NCT00568633TerminatedPhase 3

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

Stanford University5 sites in 1 country58 target enrollmentStarted: August 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
58
Locations
5
Primary Endpoint
Overall Survival (OS)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Allo-HSCT + TLI + ATG

Experimental

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Intervention: Allogeneic HSCT (Procedure)

Allo-HSCT + TLI + ATG

Experimental

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Intervention: Anti-thymocyte globulin (ATG) (Drug)

Allo-HSCT + TLI + ATG

Experimental

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Intervention: Cyclosporine (CSP) (Drug)

Allo-HSCT + TLI + ATG

Experimental

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Intervention: Mycophenolate mofetil (MMF) (Drug)

Allo-HSCT + TLI + ATG

Experimental

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Intervention: Total lymphoid irradiation (TLI) (Radiation)

Allo-HSCT + TLI + ATG

Experimental

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Intervention: Methylprednisolone sodium succinate (Drug)

Best Standard Care

Active Comparator

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional 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

Intervention: Best standard care (Drug)

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: 2 years

Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion).

Secondary Outcomes

  • Early Graft Loss(2 years)
  • Disease-free Survival (DFS)(2 years)
  • Non-relapse Mortality(2 years)
  • Complete Donor Hematopoietic Cell Chimerism(2 years)
  • Patients Completing the Intended Therapy in Both Arms(2 years)
  • Relapse Rate(2 years)
  • Transplant-related Mortality(100 days and 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert Lowsky

Professor of Medicine

Stanford University

Study Sites (5)

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