SCT Plus Immune Therapy in Average Risk AML/MDS

October 24, 2023 updated by: Mitchell Cairo, New York Medical College

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

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Estimated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Valhalla, New York, United States, 10595
        • New York Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day +42
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.
1 year
to determine toxicity
Time Frame: 1 year
to monitor for serious adverse events related to protocol investigational therapy
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
Chimerism
Time Frame: 1 year
To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
1 year
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.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2012

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimated)

April 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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