SCT Plus Immune Therapy in Average Risk AML/MDS

Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02117297

Enrollment

Registered

2014-04-17

Start date

2012-01-12

Completion date

2023-03-30

Last updated

2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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.

Interventions

DRUGGemtuzumab Ozogamicin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 25 Years

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

Design outcomes

Primary

Measure	Time frame	Description
to evaluate incidence of graft failure	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	1 year	Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS.
to determine toxicity	1 year	to monitor for serious adverse events related to protocol investigational therapy

Secondary

Measure	Time frame	Description
Minor histocompatibility antigen	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	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	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026