Clinical trial · Interventional
Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
- 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. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with 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 |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Efficacy in terms of complete remission rate
- measure
- Toxicity
- measure
- Pharmacokinetics
Secondary outcomes (1)
- measure
- Correlate clinical response to laboratory studies of drug susceptibility
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate * More than 20% blasts by morphologic criteria * Relapsed disease ≥ 3 months after prior complete remission * Blasts CD33-positive by flow cytometry * No primary hematologic disorder that preceded initial presentation with AML * No documented secondary AML related to prior chemotherapy or toxin exposure * No acute promyelocytic leukemia (FAB M3) * Not a candidate for transplant therapy * No active CNS leukemia PATIENT CHARACTERISTICS: Age * 60 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC ≤ 30,000/mm\^3 (hydroxyurea allowed) Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST or ALT ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 mg/dL Other * HIV negative * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not planning hematopoietic stem cell transplantation immediately after study therapy Chemotherapy * See Disease Characteristics * See Hematopoietic Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 1 month since prior investigational agents * No other concurrent anticancer therapy * No administration of any of the following for 24 hours after cyclosporine administration: * Diltiazem * Verapamil * Erythromycin * Clarithromycin * Metoclopramide * Phenytoin * Rifampin * Phenobarbital * Aminoglycosides * Amphotericin B * Vancomycin * Cimetidine * Ranitidine * Trimethoprim/sulfamethoxazole * Ketoconazole * Fluconazole * Itraconazole * Voriconazole * Carbamazepine
References
Publications (0)
Data not yet available