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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02221310
Other study ID # NYMC-515
Secondary ID L-10,349
Status Completed
Phase Phase 2
First received
Last updated
Start date December 7, 2011
Est. completion date April 4, 2023

Study information

Verified date October 2023
Source New York Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 4, 2023
Est. primary completion date April 4, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 25 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States New York Medical College Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

References & Publications (1)

Satwani P, Bhatia M, Garvin JH Jr, George D, Dela Cruz F, Le Gall J, Jin Z, Schwartz J, Duffy D, van de Ven C, Foley S, Hawks R, Morris E, Baxter-Lowe LA, Cairo MS. A Phase I study of gemtuzumab ozogamicin (GO) in combination with busulfan and cyclophosphamide (Bu/Cy) and allogeneic stem cell transplantation in children with poor-risk CD33+ AML: a new targeted immunochemotherapy myeloablative conditioning (MAC) regimen. Biol Blood Marrow Transplant. 2012 Feb;18(2):324-9. doi: 10.1016/j.bbmt.2011.11.007. Epub 2011 Nov 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate 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 1 year
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