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SCT Plus Immune Therapy in Average Risk AML/MDS

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ClinicalTrials.gov Identifier: NCT02117297
Recruitment Status : Recruiting
First Posted : April 17, 2014
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College

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
Acute Myelogenous Leukemia Myelodysplastic Syndrome 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
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)(IND 111024)
Study Start Date : November 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021


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 Name: Mylotarg



Primary Outcome Measures :
  1. to evaluate incidence of graft failure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    to monitor for serious adverse events related to protocol investigational therapy


Secondary Outcome Measures :
  1. Minor histocompatibility antigen [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 >75 years
  • Seropositive for HIV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117297


Contacts
Contact: Mitchell S. Cairo, MD (914) 594-2150 mitchell_cairo@nymc.edu
Contact: Erin Morris, RN (714) 964-5359 erin_morris@nymc.edu

Locations
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell S Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Erin Morris, RN    714-964-5359    erin_morris@nymc.edu   
Principal Investigator: Mitchell S. Cairo, MD         
Sponsors and Collaborators
New York Medical College
Investigators
Principal Investigator: Mitchell S. Cairo, M.D. New York Medical College

Responsible Party: Mitchell Cairo, Principal Investigator, New York Medical College
ClinicalTrials.gov Identifier: NCT02117297     History of Changes
Other Study ID Numbers: NYMC-504
L 10,394 ( Other Identifier: New York Medical College )
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Gemtuzumab
Antineoplastic Agents