SCT Plus Immune Therapy in Average Risk AML/MDS

Myelodysplastic Syndrome Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

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