Clinical trial · Interventional
Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia
- 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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older 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 |
|---|---|---|---|
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| oblimersen sodium | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed CD33+ acute myeloid leukemia (AML) * In first relapse from chemotherapy * Complete response lasting at least 3 months before relapse * No CNS leukemia * No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia) PATIENT CHARACTERISTICS: Age: * 60 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC less than 30,000/mm\^3 * No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation Hepatic: * Bilirubin no greater than 1.5 mg/dL * PT and PTT no greater than 1.5 times upper limit of normal OR * INR no greater than 1.3 * No history of chronic hepatitis or cirrhosis Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No uncontrolled congestive heart failure * No New York Heart Association class III or IV heart disease Pulmonary: * No severe pulmonary disease Other: * HIV negative * No other concurrent medical disease that would preclude study entry * No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli * No other concurrent malignancy * No known human anti-human antibodies * No uncontrolled seizure disorder * No active uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior allogeneic or autologous stem cell transplantation * No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195) Chemotherapy: * See Disease Characteristics * At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea Endocrine therapy: * Not specified Radiotherapy: * At least 2 weeks since prior systemic radiotherapy Surgery: * At least 2 weeks since prior major surgery * No prior organ allograft Other: * At least 3 weeks since prior antileukemic therapy and recovered * No other concurrent investigational therapy * No concurrent immunosuppressive therapy
References
Publications (1)
- RESULTMoore J, Seiter K, Kolitz J, Stock W, Giles F, Kalaycio M, Zenk D, Marcucci G. A Phase II study of Bcl-2 antisense (oblimersen sodium) combined with gemtuzumab ozogamicin in older patients with acute myeloid leukemia in first relapse. Leuk Res. 2006 Jul;30(7):777-83. doi: 10.1016/j.leukres.2005.10.025. Epub 2006 May 26. PMID 16730060