Clinical Trial: AML Therapy With Irradiated Allogeneic Cells

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: AML Therapy With Irradiated Allogeneic Cells

Brief Summary: This pilot clinical trial studies if cells donated by a close genetic relative can help keep acute myeloid leukemia (AML) from coming back after standard chemotherapy induces a complete remission. Blood cells obtained from a donor include a variety of blood cells that may trigger the patient's immune system to react against AML cells.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Toxicity of haploidentical allogeneic cellular therapy in patients in complete remission (CR) (or CR with incomplete platelet recovery [CRp]) after induction chemotherapy with fludarabine (fludarabine phosphate)-cytarabine.

II. Efficacy of haploidentical allogeneic cellular therapy in patients in CR (or CRp) after induction chemotherapy with fludarabine-cytarabine (remission rates at 6, 12, 18, 24 months).

SECONDARY OBJECTIVES:

I. Immunologic parameters before and after haploidentical therapy: host anti-leukemia T cells; host regulatory T cells.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate intravenously (IV) over 1 hour once daily (QD) for 5 days and cytarabine IV over 4 hours for 5 days. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.

ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated donor lymphocyte infusion (DLI) of 3 x 10^8 cluster of differentiation (CD)3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 2 years.


Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome:

  • Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]
  • Response rate, determined by allogeneic cell therapy-related mortality [ Time Frame: Up to 2 years ]
  • Response rate, determined by duration of complete remission [ Time Frame: Up to 2 years ]
    Patients will be scored as being in continuous remission at 2 years or having relapsed sooner.


Original Primary Outcome: Same as current

Current Secondary Outcome: Progression free survival probability for CR [ Time Frame: At 2 years ]

Calculated using Kaplan-Meier estimation method. Corresponding 95% confidence interval will be provided.


Original Secondary Outcome: Same as current

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: April 2, 2014
Date Started: February 2014
Date Completion:
Last Updated: February 1, 2017
Last Verified: February 2017