SCT Plus Immune Therapy in Average Risk AML/MDS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-12

Study Completion Date

2023-03-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Myelogenous Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gemtuzumab Ozogamicin

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.

Group Type EXPERIMENTAL

Gemtuzumab Ozogamicin

Intervention Type DRUG

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

Interventions

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Gemtuzumab Ozogamicin

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

Intervention Type DRUG

Other Intervention Names

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Mylotarg

Eligibility Criteria

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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

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No