Clinical Trial: Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant

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

Official Title: Phase I/II Study of Adoptive Immunotherapy With CD8+ Proteinase 3 (Myeloblastin)-Specific CTL Clones for HLA-A2+ Patients With Relapse or Progression of Disease After Allogeneic Hematopoietic Stem Cel

Brief Summary: This phase I/II trial is studies the side effects of giving therapeutic allogeneic lymphocytes together with aldesleukin and to see how well it works in treating patients with high-risk or recurrent myeloid leukemia after undergoing donor stem cell transplant. Biological therapies, such as therapeutic autologous lymphocytes, may stimulate the immune system in different ways and stop cancer cells from growing. Aldesleukin may stimulate the white blood cells to kill cancer cells. Giving therapeutic autologous lymphocytes together with aldesleukin may kill more cancer cells

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the safety and potential toxicities associated with infusing donor CD8+ cytotoxic T lymphocytes (CTL) clones specific for Proteinase 3 (Myeloblastin) in patients with relapse/progression of high risk myeloid leukemias after transplant.

SECONDARY OBJECTIVES:

I. To determine the in vivo persistence of transferred T cells and assess migration to the bone marrow, a predominant site of leukemic relapse.

II. To determine if adoptively transferred proteinase 3 (PR3)-specific T cells mediate antileukemic activity.

OUTLINE:

Patients receive allogeneic CD8+ PR3-specific CTLs intravenously (IV) over 1-2 hours on days 0, 7, 14, 28, and 49 and aldesleukin subcutaneously (SC) twice daily on days 28-41 and 49-63 in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up every 1-3 months.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: Toxicity rate associated with infusing donor CD8+CTL clones specific for PR3 [ Time Frame: From the first CTL infusion to 4 weeks after the final dose of CTL or IL-2 ]

Original Primary Outcome:

Current Secondary Outcome:

  • In vivo persistence of transferred T-cells and assessment of migration to the bone marrow [ Time Frame: Baseline and days +7, +11, +14, +21, and +28 after each CTL infusion ]
  • Duration of response as assessed by PCR or cytogenetic analysis of peripheral blood and bone marrow samples [ Time Frame: Days +0, +15, +29, +50, +63, and at approximately 1 month after completion of all therapy ]
  • Proportion of responders [ Time Frame: Approximately one month after completion of all therapy ]


Original Secondary Outcome:

Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: January 24, 2003
Date Started: September 2002
Date Completion:
Last Updated: February 13, 2017
Last Verified: February 2017