Clinical trial · Interventional
Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
A Pilot Study of Phenylbutyrate, Dexamethasone and GM-CSF in Refractory or Relapsed t(8;21) 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining phenylbutyrate, dexamethasone, and sargramostim in treating patients who have refractory or 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| oral sodium phenylbutyrate | Drug | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of t(8;21) acute myeloid leukemia (AML) * Failed standard induction chemotherapy or stem cell transplantation (SCT) OR * Relapsed after standard induction chemotherapy or SCT OR * Refused or not a candidate for SCT or matched allogeneic sibling bone marrow transplantation or donor lymphocyte infusion OR * Refused of not a candidate for autologous SCT or bone marrow transplantation * No CNS leukemia PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 7 days Hematopoietic: * Not specified Hepatic: * AST or ALT no greater than 3 times upper limit of normal (ULN) * Bilirubin no greater than 3 times ULN * No hepatic disease that would preclude study Renal: * Creatinine no greater than 2 mg/dL * Creatinine clearance at least 60 mL/min * No renal disease that would preclude study Cardiovascular: * No cardiac disease that would preclude study * No New York Heart Association class III or IV heart disease * No myocardial infarction within past 8 weeks Other: * No active infection except cystitis * Not pregnant or nursing * No altered mental status or seizure disorder * No other serious disease that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 3 weeks since prior investigational antineoplastic drugs
References
Publications (0)
Data not yet available