Clinical trial · Interventional
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
NCT02221310CI-TRIAL-00070808completedPhase 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)
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).
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
- Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.
- interventionNames
- Drug: Gemtuzumab Ozogamicin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 1 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSatwani 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. PMID 22079471