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

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

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

Sponsors & Collaborators

• Genzyme, a Sanofi Company

  collaborator INDUSTRY

• Stanford University

  lead OTHER

Principal Investigators

• Robert Lowsky · Stanford University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2015-12-31

Completion

2015-12-31

FDA Drug

Yes

Countries

• United States

Study Locations