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SCT Plus Immune Therapy in Average Risk AML/MDS

Sponsor
New York Medical College (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02117297
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
145
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Gemtuzumab Ozogamicin
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)
Study Start Date :
Nov 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gemtuzumab Ozogamicin

Consolidation 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.

Drug: Gemtuzumab Ozogamicin
Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.
Other Names:
  • Mylotarg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. to evaluate incidence of graft failure [Day +42]

      If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.

    2. to evaluate survival rates [1 year]

      Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS.

    3. to determine toxicity [1 year]

      to monitor for serious adverse events related to protocol investigational therapy

    Secondary Outcome Measures

    1. Minor histocompatibility antigen [1 year]

      To measure the minor histocompatibility antigen expression on AML tissue, donor and recipient, and the development of MHA specific CTLs post AlloSCT.

    2. Chimerism [1 year]

      To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.

    3. Graft-versus-host disease [1 Year]

      To estimate the risk of acute and chronic GVHD following RI AlloSCT and FK506/MMF GVHD prophylaxis in patients with average risk AML/MDS.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York Medical College Valhalla New York United States 10595

    Sponsors and Collaborators

    • New York Medical College

    Investigators

    • Principal Investigator: Mitchell S. Cairo, M.D., New York Medical College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitchell Cairo, Principal Investigator, New York Medical College
    ClinicalTrials.gov Identifier:
    NCT02117297
    Other Study ID Numbers:
    • NYMC-504
    • L 10,394
    First Posted:
    Apr 17, 2014
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Preleukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Myelodysplastic Syndromes
    Gemtuzumab

    Study Results

    No Results Posted as of Nov 15, 2021