Clinical Trials /

SCT Plus Immune Therapy in Average Risk AML/MDS

NCT02117297

Description:

Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: SCT Plus Immune Therapy in Average Risk AML/MDS
  • Official Title: Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)

Clinical Trial IDs

  • ORG STUDY ID: NYMC-504
  • SECONDARY ID: L 10,394
  • NCT ID: NCT02117297

Conditions

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome

Interventions

DrugSynonymsArms
Gemtuzumab OzogamicinMylotargGemtuzumab Ozogamicin

Purpose

Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.

Detailed Description

      Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) +
      Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning
      regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab
      and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk
      AML/MDS meeting eligibility criteria.
    

Trial Arms

NameTypeDescriptionInterventions
Gemtuzumab OzogamicinExperimentalConsolidation therapy with GO will be administered between days 60 and 180 post transplantation when the ANC is >1000/mm3 and platelet count is >40,000/mm3 untransfused x 3 days after AlloSCT and again at minimum 8 weeks later.
  • Gemtuzumab Ozogamicin

Eligibility Criteria

        Inclusion Criteria:

        Disease Status:

          -  AML 1st CR with a matched family donor

          -  AML 1st CR with unrelated donor

          -  AML 2nd CR or CRP

          -  MDS and < or = 5% bone marrow myeloblasts at diagnosis

        Disease Immunophenotype:

          -  Disease must express a minimum of > or = 10% CD33 positivity for patients with AML

        Organ Function:

          -  Adequate renal function, adequate liver function, adequate cardiac function, adequate
             pulmonary function

        Exclusion Criteria:

          -  Patients with active CNS AML disease at time of preparative regimen

          -  Secondary MDS

          -  Poor cytogenetics

          -  Female patients who are pregnant

          -  Karnofsky <70% or Lansky <50% if 10 years or less

          -  Age >25 years

          -  Seropositive for HIV
      
Maximum Eligible Age:25 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:to evaluate incidence of graft failure
Time Frame:Day +42
Safety Issue:
Description:If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.

Secondary Outcome Measures

Measure:Minor histocompatibility antigen
Time Frame:1 year
Safety Issue:
Description:To measure the minor histocompatibility antigen expression on AML tissue, donor and recipient, and the development of MHA specific CTLs post AlloSCT.
Measure:Chimerism
Time Frame:1 year
Safety Issue:
Description:To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
Measure:Graft-versus-host disease
Time Frame:1 Year
Safety Issue:
Description:To estimate the risk of acute and chronic GVHD following RI AlloSCT and FK506/MMF GVHD prophylaxis in patients with average risk AML/MDS.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:New York Medical College

Last Updated

February 13, 2020