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

Sponsor

New York Medical College (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02221310

Collaborator

(none)

Enrollment

Location

Arm

139

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome	Drug: Gemtuzumab Ozogamicin	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study of Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamide (Immunochemotherapy) and Allogeneic Stem Cell Transplantation in Patients With High Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gemtuzumab Ozogamicin Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.	Drug: Gemtuzumab Ozogamicin Gemtuzumab Ozogamicin 7.5 mg/m^2/dose given IV over 2 hours once during conditioning Other Names: Mylotarg

Arm

Intervention/Treatment

Experimental: Gemtuzumab Ozogamicin

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

Drug: Gemtuzumab Ozogamicin

Gemtuzumab Ozogamicin 7.5 mg/m^2/dose given IV over 2 hours once during conditioning

Other Names:

Mylotarg

Outcome Measures

Primary Outcome Measures

Response rate [1 year]
overall response rate (CR + PR) in patients receiving GO, busulfan and cyclophosphamide and AlloSCT in patients with measurable disease (relapse/refractory) with high risk CD33+ AML/MDS

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 25 Years

Sexes Eligible for Study:

All

Accepts 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.