Clinical trial · Interventional
Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
A Phase I Study of G3139 (NSC 683428) in Combination With Salvage Chemotherapy for Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL)
- 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 augmerosen plus fludarabine and cytarabine in treating patients who have refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Gene therapy such as augmerosen may make cancer cells more sensitive to chemotherapy drugs. Combining more than one drug with augmerosen may kill more cancer cells.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| oblimersen sodium | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive augmerosen IV continuously on days 1-10 and filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover. Patients receive fludarabine IV over 30 minutes followed 3.5 hours later by cytarabine IV over 4 hours on days 6-10. Patients who achieve complete response (CR) receive a second course beginning 4 weeks after completion of the first course. Patients who achieve CR and have a matched sibling or unrelated bone marrow donor may undergo allogeneic bone marrow transplantation. Cohorts of 3-6 patients receive escalating doses of fludarabine and cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
- interventionNames
- Biological: filgrastim
- Biological: oblimersen sodium
- Drug: cytarabine
- Drug: fludarabine phosphate
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia * Marrow cellularity must be at least 20% * Must have diagnostic lumbar puncture and treatment with prophylactic intrathecal methotrexate within 1 week prior to entering study * No active CNS involvement * CNS involvement allowed if no residual leukemic cells are detected in CSF following intrathecal chemotherapy PATIENT CHARACTERISTICS: * Age: 16 and over * Performance status: ECOG 0-2 * Life expectancy: At least 4 weeks * Bilirubin no greater than 2 times upper limit of normal(ULN) * ALT and AST no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN\* * Unless attributable to malignancy * Creatinine no greater than 1.5 mg/dL unless attributable to malignancy * No symptomatic congestive heart failure * No unstable angina pectoris No or cardiac arrhythmia * Resting cardiac ejection fraction no less than 45% unless attributable to malignancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before and during study * No history of allergy to study medications * No uncontrolled concurrent illness * No active infection * No serious medical or psychiatric illness that would preclude informed consent or limit survival to less than 4 weeks PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior chemotherapy except hydroxyurea * No concurrent corticosteroids except for grade 4 toxicity unresponsive to all other agents * At least 4 weeks since prior radiotherapy * No other concurrent investigational or standard agents or therapies for leukemia
References
Publications (0)
Data not yet available