Clinical Trials /

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

NCT02221310

Description:

Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS
  • Official Title: A Pilot Study of Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamide (Immunochemotherapy) and Allogeneic Stem Cell Transplantation in Patients With High Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Clinical Trial IDs

  • ORG STUDY ID: NYMC-515
  • SECONDARY ID: L-10,349
  • NCT ID: NCT02221310

Conditions

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome

Interventions

DrugSynonymsArms
Gemtuzumab OzogamicinMylotargGemtuzumab Ozogamicin

Purpose

Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).

Detailed Description

      Gemtuzumab ozogamicin in combination with busulfan and cyclophosphamide (immunochemotherapy)
      conditioning followed by allogeneic stem cell transplantation + anti-thymocyte globulin
      (unrelated donors only) in patients with high risk CD33+AML or MDS meeting eligibility
      criteria.
    

Trial Arms

NameTypeDescriptionInterventions
Gemtuzumab OzogamicinExperimentalConditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.
  • Gemtuzumab Ozogamicin

Eligibility Criteria

        Inclusion Criteria:

          -  Disease Status:

               -  History of AML Induction/Reinduction Failure

               -  AML 1st Complete Remission (CR) with poor cytogenetics

               -  AML 2nd CR with minimal residual disease (MRD)

               -  AML 3rd CR

               -  AML in refractory relapse but ≤25% bone marrow leukemia blasts

               -  MDS with >6% bone marrow blasts at diagnosis

               -  Secondary MDS with ≤5% bone marrow myeloblasts at diagnosis

        Disease Immunophenotype:

Disease must express a minimum of >/= 10% CD33+ for patients with AML

        Organ Function:

        • Adequate renal function, adequate liver function, adequate cardiac function, adequate
        pulmonary function Age: ≤25 years of age Donor: matched family donor, unrelated cord blood
        donor, unrelated adult donor

        Exclusion Criteria:

          -  Patients with active central nervous system (CNS) AML/MDS disease at time of
             conditioning therapy

          -  Female patients who are pregnant

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

          -  Age >25 years

          -  Has received gemtuzumab in the previous 30 days or has not recovered from prior
             gemtuzumab therapy.
      
Maximum Eligible Age:25 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response rate
Time Frame:1 year
Safety Issue:
Description:overall response rate (CR + PR) in patients receiving GO, busulfan and cyclophosphamide and AlloSCT in patients with measurable disease (relapse/refractory) with high risk CD33+ AML/MDS

Details

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

Trial Keywords

  • targeted therapy
  • leukemia
  • MDS
  • immune therapy

Last Updated

September 26, 2019