SCT Plus Immune Therapy in Average Risk AML/MDS

New York Medical College

Status and phase: Completed; Phase 2

Conditions: Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Treatments: Drug: Gemtuzumab Ozogamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02117297

L 10,394 (Other Identifier)

NYMC-504

Details and patient eligibility

About

Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: Under 25 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Gemtuzumab Ozogamicin

Experimental group

Description:

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.

Treatment:

Drug: Gemtuzumab Ozogamicin