Acute Myeloid Leukemia Clinical Trial

SCT Plus Immune Therapy in Average Risk AML/MDS

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.

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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.

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Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

26

Study ID:

NCT02117297

Recruitment Status:

Active, not recruiting

Sponsor:

New York Medical College

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There is 1 Location for this study

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New York Medical College
Valhalla New York, 10595, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

26

Study ID:

NCT02117297

Recruitment Status:

Active, not recruiting

Sponsor:


New York Medical College

How clear is this clinincal trial information?

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