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Completed

NCT Number: NCT02117297

SCT Plus Immune Therapy in Average Risk AML/MDS

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

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Key information

Conditions

Acute Myelogenous Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York Medical College

Valhalla, New York, 10595, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemtuzumab Ozogamicin

Drug

Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.

Other names: Mylotarg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York Medical College

Other

Registry information

Official study title

Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2014
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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