Clinical trial · Interventional
SCT Plus Immune Therapy in Average Risk AML/MDS
Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)
NCT02117297CI-TRIAL-00070809completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemtuzumab Ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemtuzumab Ozogamicin
- description
- Consolidation therapy with GO will be administered between days 60 and 180 post transplantation when the ANC is \>1000/mm3 and platelet count is \>40,000/mm3 untransfused x 3 days after AlloSCT and again at minimum 8 weeks later.
- interventionNames
- Drug: Gemtuzumab Ozogamicin
Primary outcomes (3)
- measure
- to evaluate incidence of graft failure
- timeFrame
- Day +42
- description
- If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.
- measure
- to evaluate survival rates
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.