SCT Plus Immune Therapy in Average Risk AML/MDS

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Treatments: Gemtuzumab

Criteria

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