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

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

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

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

  • United States
    • 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:

    • 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.

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
Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.
Drug: Gemtuzumab Ozogamicin
Gemtuzumab Ozogamicin 7.5 mg/m^2/dose given IV over 2 hours once during conditioning
Other Names:
  • Mylotarg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 1 year
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
1 year

Collaborators and Investigators

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

Sponsor

New York Medical College

Investigators

  • Principal Investigator: Mitchell S Cairo, MD, New York Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 7, 2011

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimated)

August 20, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYMC-515
  • L-10,349 (Other Identifier: New York Medical College)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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