SCT Plus Immune Therapy in Average Risk AML/MDS
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any - 25 |
| Updated: | 11/3/2018 |
| Start Date: | November 2011 |
| End Date: | December 2021 |
| Contact: | Mitchell S. Cairo, MD |
| Email: | mitchell_cairo@nymc.edu |
| Phone: | (914) 594-2150 |
Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)
Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab
Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) +
Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning
regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab
and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk
AML/MDS meeting eligibility criteria.
Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning
regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab
and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk
AML/MDS meeting eligibility criteria.
Inclusion Criteria:
Disease Status:
- AML 1st CR with a matched family donor
- AML 1st CR with unrelated donor
- AML 2nd CR or CRP
- MDS and < or = 5% bone marrow myeloblasts at diagnosis
Disease Immunophenotype:
- Disease must express a minimum of > or = 10% CD33 positivity for patients with AML
Organ Function:
- Adequate renal function, adequate liver function, adequate cardiac function, adequate
pulmonary function
Exclusion Criteria:
- Patients with active CNS AML disease at time of preparative regimen
- Secondary MDS
- Poor cytogenetics
- Female patients who are pregnant
- Karnofsky <70% or Lansky <50% if 10 years or less
- Age >25 years
- Seropositive for HIV
We found this trial at
1
site
40 Sunshine Cottage Road
Valhalla, New York 10595
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Mitchell S. Cairo, MD
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
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