Clinical trial · Interventional
Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia: Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes
- 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 filgrastim and 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. It is not yet known whether combination chemotherapy is more effective followed by filgrastim or sargramostim in treating leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractory acute myeloid leukemia or acute lymphoblastic 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia by morphology, cytochemical staining, and flow cytometry * In first or subsequent relapse or refractory disease after at least 1 prior treatment regimen * Antecedent hematologic disorders allowed except Philadelphia chromosome-positive chronic myelogenous leukemia PATIENT CHARACTERISTICS: Age * 15 and over Performance status * 0-3 Life expectancy * At least 4 weeks Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2 times normal\* * SGOT no greater than 2 times normal\* NOTE: \*Unless directly attributable to leukemia Renal * Creatinine no greater than 1.5 times normal\* NOTE: \*Unless directly attributable to leukemia Cardiovascular * Ejection fraction at least 45%\* NOTE: \*Unless directly attributable to leukemia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent medical or psychiatric illness that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy * Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation allowed * Prior cytokines allowed Chemotherapy * Prior chemotherapy allowed Endocrine therapy * No concurrent corticosteroids except for treatment of severe vomiting that is refractory to standard agents Radiotherapy * Prior radiotherapy allowed Surgery * Not specified
References
Publications (0)
Data not yet available