Clinical trial · Interventional
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome
A Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
NCT00968071CI-TRIAL-00009675completedPhase 2Results postedClinicalTrials.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)
The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
| Gemtuzumab Ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine + Gemtuzumab Ozogamicin
- description
- Decitabine 20 mg/m\^2 intravenously (IV) over an hour and half daily for 5 days, Gemtuzumab Ozogamicin 3 mg/m\^2 IV on day 5.
- interventionNames
- Drug: Decitabine
- Drug: Gemtuzumab Ozogamicin
Primary outcomes (1)
- measure
- Number of Participants With Complete Response (CR)
- timeFrame
- Up to 36 weeks
- description
- Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral anc \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age \>/= to 16 years at the time of signing the informed consent form. 3. Diagnosis of Acute myeloid leukemia (AML) \[other than acute promyelocytic leukemia (APL)\] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk Intermediate-2 or high by International Prognostic Scoring System (IPSS) or \>/= to 10% blasts) MDS will also be eligible. All non-hematological toxicity of previous cancer therapy should have resolved to \</= grade 1 (except alopecia or other toxicities not involving major organs). 4. Eastern Cooperative Oncology Group (ECOG) performance status of \</= to 3 at study entry. 5. Laboratory test results within these ranges (unless due to leukemia): Serum creatinine \</= 2 mg/dL Total bilirubin \</= 2 mg/dL aspartate aminotransferase (AST) (SGOT) and/or alanine aminotransferase (ALT) (SGPT) \</= 2.5 x ULN or \</= 5 times Upper limit of normal (ULN) if related to disease 6. Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Exclusion Criteria: 1. Pregnant or breastfeeding females. 2. Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk. 3. Use of any other experimental drug or therapy for leukemia within 7 days unless there is clear evidence of rapid disease progression. 4. Use of hydrea to control proliferative disease will be allowed prior to starting therapy on study and for up to 7 days each during cycle 1-3 (Maximum daily dose of 7gm).
References
Publications (0)
Data not yet available
No reference posted for this study.