SCT Plus Immune Therapy in Average Risk AML/MDS
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|ClinicalTrials.gov Identifier: NCT02117297|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2014
Last Update Posted : September 27, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Myelodysplastic Syndrome||Drug: Gemtuzumab Ozogamicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
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.
Drug: Gemtuzumab Ozogamicin
Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.
Other Name: Mylotarg
- 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.
- 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.
- to determine toxicity [ Time Frame: 1 year ]to monitor for serious adverse events related to protocol investigational therapy
- 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.
- Chimerism [ Time Frame: 1 year ]To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
- 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.
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|Ages Eligible for Study:||up to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 must express a minimum of > or = 10% CD33 positivity for patients with AML
- Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117297
|United States, New York|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|Principal Investigator:||Mitchell S. Cairo, M.D.||New York Medical College|
|Responsible Party:||Mitchell Cairo, Principal Investigator, New York Medical College|
|Other Study ID Numbers:||
L 10,394 ( Other Identifier: New York Medical College )
|First Posted:||April 17, 2014 Key Record Dates|
|Last Update Posted:||September 27, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs