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SCT Plus Immune Therapy in Average Risk AML/MDS

Primary Purpose

Acute Myelogenous Leukemia, Myelodysplastic Syndrome

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemtuzumab Ozogamicin
Sponsored by
New York Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemtuzumab Ozogamicin

Arm Description

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.

Outcomes

Primary Outcome Measures

to evaluate incidence of graft failure
If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.
to evaluate survival rates
Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS.
to determine toxicity
to monitor for serious adverse events related to protocol investigational therapy

Secondary Outcome Measures

Minor histocompatibility antigen
To measure the minor histocompatibility antigen expression on AML tissue, donor and recipient, and the development of MHA specific CTLs post AlloSCT.
Chimerism
To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
Graft-versus-host disease
To estimate the risk of acute and chronic GVHD following RI AlloSCT and FK506/MMF GVHD prophylaxis in patients with average risk AML/MDS.

Full Information

First Posted
April 8, 2014
Last Updated
September 26, 2022
Sponsor
New York Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02117297
Brief Title
SCT Plus Immune Therapy in Average Risk AML/MDS
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 Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemtuzumab Ozogamicin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemtuzumab Ozogamicin
Other Intervention Name(s)
Mylotarg
Intervention Description
Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.
Primary Outcome Measure Information:
Title
to evaluate incidence of graft failure
Description
If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.
Time Frame
Day +42
Title
to evaluate survival rates
Description
Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS.
Time Frame
1 year
Title
to determine toxicity
Description
to monitor for serious adverse events related to protocol investigational therapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Minor histocompatibility antigen
Description
To measure the minor histocompatibility antigen expression on AML tissue, donor and recipient, and the development of MHA specific CTLs post AlloSCT.
Time Frame
1 year
Title
Chimerism
Description
To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
Time Frame
1 year
Title
Graft-versus-host disease
Description
To estimate the risk of acute and chronic GVHD following RI AlloSCT and FK506/MMF GVHD prophylaxis in patients with average risk AML/MDS.
Time Frame
1 Year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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 >25 years Seropositive for HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S. Cairo, M.D.
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

SCT Plus Immune Therapy in Average Risk AML/MDS

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