Clinical trial · Interventional
Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
A Phase I Study of G3139 ( NSC # 683428) in Combination With Cytarabine and Daunorubicin in Previously Untreated Patients With Acute Myeloid Leukemia (AML)>= 60 Years of Age
NCT00039117CI-TRIAL-00020080completedPhase 1ClinicalTrials.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)
Phase I trial to study the effectiveness of combining oblimersen with cytarabine and daunorubicin in treating older patients who have previously untreated acute myeloid leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may help cytarabine and daunorubicin kill more cancer cells by making them more sensitive to chemotherapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ALIAS | 0.85 |
| Secondary Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Untreated Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| oblimersen sodium | Biological | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- INDUCTION THERAPY: Patients receive oblimersen (G3139) IV continuously on days 1-10 and cytarabine IV continuously on days 4-10. Patients also receive daunorubicin IV daily on days 4-6. Patients with bone marrow cellularity of at least 20% and at least 5% leukemic blasts at day 17 or evidence of refractory disease receive a second induction comprising G3139 IV continuously on days 1-8, cytarabine IV continuously on days 4-8, and daunorubicin IV on days 4-5. CONSOLIDATION THERAPY: Beginning no sooner than 14 days after hematologic recovery from induction therapy, patients receive G3139 IV continuously on days 1-8 and cytarabine IV over 4 hours on days 4-8. Patients receive a second course of consolidation therapy no sooner than 14 days after hematologic recovery from the first course.
- interventionNames
- Biological: oblimersen sodium
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- MTD of cytarabine and daunorubicin in combination with G3139, defined as the dose level just below the dose level at which DLT is observed in 2 patients, graded according to NCI CTC version 2.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary or secondary acute myeloid leukemia (AML) * More than 20% bone marrow blasts * Myelodysplastic syndromes (MDS) or a chronic myeloproliferative disorder antecedent to AML allowed * Therapy-related AML allowed * No acute promyelocytic leukemia * At least 4 weeks * Bilirubin no greater than 2 mg/dL * ALT and AST no greater than 2 times upper limit of normal (unless directly attributable to AML) * Creatinine no greater than 2.5 mg/dL * Ejection fraction at least 50% by MUGA or echocardiogram * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No allergy to any of the study medications * No other uncontrolled concurrent illness * No serious medical or psychiatric illness that would preclude giving informed consent * Not pregnant or nursing * Fertile patients must use effective contraception * No prior therapy for primary AML except emergency leukapheresis * No prior anthracyclines * No prior chemotherapy for primary AML except hydroxyurea for hyperleukocytosis * At least 3 months since prior chemotherapy for MDS or chronic myeloproliferative disorders antecedent to AML * No other concurrent chemotherapy * No concurrent corticosteroids as anti-emetics * No concurrent steroids except for adrenal failure or septic shock * No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes, tamoxifen or equivalent for breast cancer prevention or adjuvant treatment, or estrogens or progestins for gynecologic indications) * No prior radiotherapy for primary AML except cranial radiotherapy for CNS leukostasis * No concurrent palliative radiotherapy * No concurrent whole brain radiotherapy * No other concurrent investigational or commercial agents or therapies * No concurrent cyclooxygenase-2 inhibitors
References
Publications (0)
Data not yet available
No reference posted for this study.