Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ 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

NCT02221310

NYMC-515

L-10,349 (Other Identifier)

Details and patient eligibility

About

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).

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.

Enrollment: 25 estimated patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Gemtuzumab Ozogamicin

Experimental group

Description:

Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.

Treatment:

Drug: Gemtuzumab Ozogamicin