Trials / Completed
CompletedNCT02221310
Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- New York Medical College · Academic / Other
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemtuzumab Ozogamicin | Gemtuzumab Ozogamicin 7.5 mg/m\^2/dose given IV over 2 hours once during conditioning |
Timeline
- Start date
- 2011-12-07
- Primary completion
- 2023-04-04
- Completion
- 2023-04-04
- First posted
- 2014-08-20
- Last updated
- 2023-10-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02221310. Inclusion in this directory is not an endorsement.