Clinical trial · Interventional
Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Randomised Induction and Post Induction Therapy in Older Patients (≥61 Years of Age) With Acute Myeloid Leukemia (AML) and Refractory Anemia With Excess Blasts (RAEB, RAEB-t)
- 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 cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes. PURPOSE: This randomized phase III trial is studying cytarabine and two different doses of daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or myelodysplastic syndromes.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm A low dose Dauno
- description
- Induction 45 mg Dauno
- interventionNames
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- type
- EXPERIMENTAL
- label
- ARM B high dose Dauno
- description
- Induction 90 mg Dauno
- interventionNames
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- type
- NO_INTERVENTION
- label
- Arm 1 no further treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Acute myeloid leukemia (AML)
* M0-M2 or M4-M7 FAB subtype
* No AML with cytogenetic abnormality t(15;17) (M3)
* Patients with secondary AML progressing from prior myelodysplasia\* or biphenotypic leukemia are eligible
* Refractory anemia with excess blasts (RAEB) or RAEB in transformation
* International Prognostic Scoring System score ≥ 1.5 NOTE: \*Any prior hematological disease of ≥ 4 months duration
* No chronic myelogenous leukemia in blastic crisis
* No prior polycythemia rubra vera
* No primary myelofibrosis
PATIENT CHARACTERISTICS:
Age
* 61 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* ALT and/or AST ≤ 2.5 times upper limit of normal (ULN)\*
* Bilirubin ≤ 2 times ULN\* NOTE: \*Unless elevation is caused by organ infiltration by AML
Renal
* Creatinine ≤ 2 times ULN\* NOTE: \*Unless elevation is caused by organ infiltration by AML
Cardiovascular
* No myocardial infarction within the past 6 months
* LVEF \> 50% by MUGA, echocardiogram, or other methods
* No unstable angina
* No unstable cardiac arrhythmia
* No severe and/or uncontrolled hypertension
Other
* No uncontrolled diabetes
* No severe and/or uncontrolled infection
* No other severe and/or uncontrolled medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 6 months since prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior induction therapy for AML or myelodysplastic syndromesReferences
Publications (0)
Data not yet available