Acute Myeloid Leukemia Clinical Trial

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

Summary

Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).

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Full Description

Gemtuzumab ozogamicin in combination with busulfan and cyclophosphamide (immunochemotherapy) conditioning followed by allogeneic stem cell transplantation + anti-thymocyte globulin (unrelated donors only) in patients with high risk CD33+AML or MDS meeting eligibility criteria.

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Eligibility Criteria

Inclusion Criteria:

Disease Status:

History of AML Induction/Reinduction Failure
AML 1st Complete Remission (CR) with poor cytogenetics
AML 2nd CR with minimal residual disease (MRD)
AML 3rd CR
AML in refractory relapse but ≤25% bone marrow leukemia blasts
MDS with >6% bone marrow blasts at diagnosis
Secondary MDS with ≤5% bone marrow myeloblasts at diagnosis

Disease Immunophenotype:

• Disease must express a minimum of >/= 10% CD33+ for patients with AML

Organ Function:

• Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function Age: ≤25 years of age Donor: matched family donor, unrelated cord blood donor, unrelated adult donor

Exclusion Criteria:

Patients with active central nervous system (CNS) AML/MDS disease at time of conditioning therapy
Female patients who are pregnant
Karnofsky <50% or Lansky <50% if 10 years or less
Age >25 years
Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT02221310

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

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Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT02221310

Recruitment Status:

Active, not recruiting

Sponsor:


New York Medical College

How clear is this clinincal trial information?

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