SCT Plus Immune Therapy in Average Risk AML/MDS
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|ClinicalTrials.gov Identifier: NCT02117297|
Recruitment Status : Recruiting
First Posted : April 17, 2014
Last Update Posted : June 20, 2018
|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)(IND 111024)|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
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.
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
|Contact: Mitchell S. Cairo, MD||(914) firstname.lastname@example.org|
|Contact: Erin Morris, RN||(714) email@example.com|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Mitchell S Cairo, MD 914-594-2150 firstname.lastname@example.org|
|Contact: Erin Morris, RN 714-964-5359 email@example.com|
|Principal Investigator: Mitchell S. Cairo, MD|
|Principal Investigator:||Mitchell S. Cairo, M.D.||New York Medical College|