Clinical trial · Interventional
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
NCT00766116CI-TRIAL-00037142completedPhase 1 / Phase 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)
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
Conditions
Conditions (1)
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Azacitidine | Drug | Azacitidine | ALIAS |
| Gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Level 1
- description
- 5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza 2 days then GO at 3 mg/m\^2
- interventionNames
- Drug: 5-Azacitidine
- Drug: Gemtuzumab ozogamicin
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Level 2
- description
- 5-Azacitidine, Gemtuzumab ozogamicin 75mg/m\^2 5-Aza for 4 days then GO at 6 mg/m\^2
- interventionNames
- Drug: 5-Azacitidine
- Drug: Gemtuzumab ozogamicin
- type
- EXPERIMENTAL
- label
- Phase I Dose Level 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Relapsed AML * Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy \> 3 months * ≥ 18 years old * Previously untreated for current AML relapse * Adequate organ function * Written informed consent Exclusion Criteria: * Pregnant or breast-feeding women * Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days * Currently receiving another investigational drug * Currently receiving other anti-cancer agents * Uncontrolled infection * HIV positive * Received previous therapy with either Mylotarg or 5-azacitidine
References
Publications (0)
Data not yet available
No reference posted for this study.