Clinical trial · Interventional
S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
- 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: 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. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CR
- timeFrame
- After induction therapy is completed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) * FAB M1-2 or M4-7 * No blastic transformation of chronic myelogenous leukemia * In first relapse after prior complete response * Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible * CD33 positive * Prior myelodysplastic syndromes or secondary AML allowed * Concurrent enrollment on SWOG-9007 (cytogenetics protocol) * No clinical or documented CNS involvement with AML PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * WBC no greater than 30,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 1.5 times ULN Renal * Not specified Cardiovascular * No unstable cardiac arrhythmias * No unstable angina Other * HIV negative * No other malignancy within the past 5 years except for the following: * Adequately treated basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix * Adequately treated stage I or II cancer currently in complete remission * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior gemtuzumab ozogamicin for AML Chemotherapy * Prior hydroxyurea to control high cell counts allowed Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 4 weeks since prior investigational agents and recovered
References
Publications (0)
Data not yet available