- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117297
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
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Valhalla, New York, United States, 10595
- New York Medical College
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-
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:
|
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
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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.
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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.
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1 year
|
Chimerism
Time Frame: 1 year
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To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
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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.
Sponsor
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Immunoconjugates
- Immunotoxins
- Gemtuzumab
Other Study ID Numbers
- NYMC-504
- L 10,394 (Other Identifier: New York Medical College)
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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