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

Myelodysplastic Syndrome Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

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