Clinical trial · Interventional
Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Randomized Phase II Study Comparing Two Administration Schedules of Flavopiridol (Alvocidib, NSC 649890, IND 46, 211) Given in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone Hydrochloride for Adults With Newly Diagnosed, Previously Untreated, Poor Risk Acute Myelogenous Leukemias (AML)
- 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)
This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone in treating patients with acute myeloid leukemia.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome | Acute Myeloid Leukemia Arising from Previous Myelodysplastic Syndrome | ALIAS | 0.90 |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
- interventionNames
- Drug: alvocidib
- Drug: mitoxantrone hydrochloride
- Drug: cytarabine
- Other: pharmacological study
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
- interventionNames
- Drug: alvocidib
- Drug: mitoxantrone hydrochloride
- Drug: cytarabine
- Other: pharmacological study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed newly diagnosed acute myeloid leukemia (AML) meeting the following criteria: * Subtypes M0, M1, M2, M4-7 * No acute promyelocytic leukemia (M3) * At least 50 years of age OR \>= 18 years of age with \>= 1 of the following poor-risk disease features: * Antecedent hematologic disorder, including myelodysplastic syndromes (MDS)-related AML or prior myeloproliferative disorder (MPD) * Treatment-related AML, AML with trilineage dysplasia * Myeloid sarcoma, myeloid proliferations related to Down Syndrome, or blastic plasmacytoid dendritic cell neoplasm * AML with trilineage dysplasia * AML with adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q, or 17p; t\[6;9\]; t\[9;22\]; trisomy 8; trisomy 13, complex karyotypes \[\>= 3 unrelated abnormalities\]), * No hyperleukocytosis with \>= 50,000 blasts/uL (leukapheresis or hydroxyurea allowed for cytoreduction immediately prior to the first dose of alvocidib) * No active CNS leukemia * ECOG performance status 0-2 * Serum creatinine =\< 2.0 mg/dL * ALT/AST =\< 5 times upper limit of normal * Bilirubin =\< 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * No active uncontrolled infection * Infection that is under active treatment allowed provided it is controlled with antibiotics * No other life-threatening illness * No mental deficits and/or psychiatric history that would preclude giving informed consent or following study requirements * At least 24 hours since prior leukapheresis or hydroxyurea for cytoreduction * Prior non-cytotoxic therapies (e.g., thalidomide or lenalidomide, interferon, cytokines, low-dose 5-azacytidine, or low-dose cytoxan) for MDS or MPD allowed * Prior chemotherapy or bone marrow/stem cell transplantation for non-AML malignancy allowed * No prior alvocidib * No other concurrent chemotherapy, radiotherapy, or immunotherapy * No other concurrent investigational or commercially-available antitumor therapies for AML * LVEF \>= 45%
References
Publications (0)
Data not yet available