Clinical trial · Interventional
Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
Idarubicin and Ara-C in Combination With Gemtuzumab-Ozogamicin (IAGO) for Young Untreated Patients, Without an HLA Identical Sibling, With High Risk MDS or AML Developing After a Preceding Period With MDS During 6 Months Duration: A Phase II Study
- 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)
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Rate of complete remission (CR) or complete remission with incomplete recovery of platelets (CRp) as measured by Cheson response criteria after the start of treatment
- measure
- Severe toxicity after the start of treatment
Secondary outcomes (3)
- measure
- Disease-free survival from CR/CRp
- measure
- Duration of overall survival
- measure
- Severity of pancytopenia and duration of recovery in patients who reached CR/CRp after the start of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* High-risk myelodysplastic syndromes (MDS), including any of the following:
* Refractory anemia with excess blasts (RAEB) with \> 10% blast cells in the bone marrow
* RAEB in transformation
* Other forms of MDS with multiple (3 or more) chromosomal abnormalities or chromosome 7 abnormalities AND/OR profound cytopenias, defined as neutrophil count \< 500/mm\^3 and/or platelet count \< 20,000/mm\^3
* Chronic myelomonocytic leukemia with \> 5% blast cells in the bone marrow
* Chronic myelomonocytic leukemia with neutrophil count \> 16,000/mm\^3 OR monocyte count \> 2,600/mm\^3
* Secondary acute myeloid leukemia supervening after overt MDS of more than 6 months in duration
* Patients with or without an HLA-identical sibling
* No active CNS leukemia
PATIENT CHARACTERISTICS:
Age
* 16 to 70
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No severe cardiovascular disease
* No arrhythmias requiring chronic treatment
* No congestive heart failure
* No symptomatic ischemic heart disease
Pulmonary
* No severe lung disease
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No HIV positivity
* No other concurrent malignant disease
* No active uncontrolled infection
* No history of alcohol abuse (i.e., averaged less than 5 alcoholic consumptions daily for the past year)
* No concurrent severe neurological or psychiatric disease
* No other psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 6 weeks since prior growth factors
Chemotherapy
* No prior intensive chemotherapy
* More than 6 weeks since prior low-dose chemotherapy or hydroxyurea
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 6 weeks since prior immunosuppressants
* No prior participation in this clinical studyReferences
Publications (0)
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