Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)

Summary

This study is a single arm Phase II, multicenter trial. It is designed to determine whether the anticipated endpoints for a T cell depleted transplant arm of a planned prospective randomized trial comparing T cell depleted and unmodified hematopoietic allografts are likely to be achieved in a multicenter study conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN or Network). The study population is patients with acute myeloid leukemia (AML) in first or second morphologic complete remission. The enrollment is 45 patients.

Based on published results of unmodified transplants from HLA-matched siblings applied to patients with AML in first or second morphologic complete remission, a significant improvement in results with a graft modified as specified in this protocol would be expected if disease-free survival (DFS) at 6 months was greater than 75%, the true incidence of transplant-related mortality at 1 year was less than 30%, and the DFS rate at 2 years was greater 70% for patients transplanted in first remission and less than 60% for patients transplanted in second remission. Additional secondary endpoints include the following: graft failure rate and incidences of acute grade II-IV and chronic graft-versus-host disease (GVHD). Additionally, the trial will have target specific doses of CD34+ progenitors and CD3+ T cells to be obtained following fractionation with the CliniMACS system. Based on the results of this trial, a Phase III trial comparing T cell depleted peripheral blood stem cell transplants (PBSCT) with unmanipulated bone marrow or unmanipulated PBSCT will be designed.

Conditions

• Leukemia, Myelocytic, Acute

Interventions

BIOLOGICAL

CD34+ selection with CliniMACS device

CD34+ cell selection will be performed according to procedures given in the CliniMACS Users Operating Manual and institutional Standard Operating Procedures (SOPs) in place and validated at the study sites. CliniMACS (Miltenyi device) to target CD34+ \>5 x 10\*6/kg and CD3+ \< 1 x 10\*5/kg

Sponsors & Collaborators

• Blood and Marrow Transplant Clinical Trials Network

  collaborator NETWORK

• National Cancer Institute (NCI)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  lead NIH

Principal Investigators

• Steven Devine, MD · Ohio State/Arthur G. James Cancer Hospital

• Parameswaran Hari, MD · Medical College of Wisconsin

• Hillard Lazarus, MD · University Hospitals of Cleveland/Case Western

• Lloyd Damon, MD · University of California, San Francisco

• Richard O'Reilly, MD · Memorial Sloan Kettering Cancer Center

• Robert Soiffer, MD · Dana Farber Cancer Institute/Brigham & Women's Hospital

• Anthony Stein, MD · City of Hope National Medical Center

• John DiPersio, MD, PhD · Washington University/Barnes Jewish Hospital

• Edward Stadtmauer, MD · University of Pennsylvania

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-06-30

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• United States

Study Locations