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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02117297
Other study ID # NYMC-504
Secondary ID L 10,394
Status Completed
Phase Phase 2
First received
Last updated
Start date January 12, 2012
Est. completion date March 30, 2023

Study information

Verified date October 2023
Source New York Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 25 Years
Eligibility 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 Design


Intervention

Drug:
Gemtuzumab Ozogamicin
Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.

Locations

Country Name City State
United States New York Medical College Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day +42
Primary to evaluate survival rates Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS. 1 year
Primary to determine toxicity to monitor for serious adverse events related to protocol investigational therapy 1 year
Secondary 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. 1 year
Secondary Chimerism To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS. 1 year
Secondary 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. 1 Year
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