Phase 2
N=172
Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome · Adult Acute Minimally Differentiated Myeloid Leukemia (M0) · Adult Acute Monoblastic Leukemia (M5a) · Adult Acute Monocytic Leukemia (M5b) · Adult Acute Myeloblastic Leukemia With Maturation (M2)
Bottom Line
View on ClinicalTrials.gov: NCT01349972 ↗Enrolled (actual)
172
Serious AEs
43.0%
Results posted
Jun 2017
Primary outcome: Primary: Complete Response Rate — 76; 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alvocidib (Drug); daunorubicin hydrochloride (Drug); mitoxantrone hydrochloride (Drug); cytarabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate |
76; 24 | — |
| SECONDARY Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade |
156; 77 | — |
| SECONDARY Disease-free Survival |
1.46; 1.85 | — |
| SECONDARY Overall Survival |
1.46; 1.850 | — |
| SECONDARY Number of Patients With Minimal Residual Disease |
26; 24 | — |
| SECONDARY Progression-free Survival |
0.81; 0.28 | — |
Summary
This randomized phase II trial is studying how alvocidib, cytarabine, and mitoxantrone hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating patients with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, mitoxantrone hydrochloride, and daunorubicin hydrochloride 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 whether giving alvocidib, cytarabine, and mitoxantrone hydrochloride is more effective than giving cytarabine and daunorubicin hydrochloride in treating patients with acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria
- All adults with established, pathologically confirmed diagnoses of newly diagnosed AML and adults with newly diagnosed AML, excluding newly diagnosed core-binding factor (CBF) AMLs and acute progranulocytic leukemia (APL, M3), will be considered eligible for study
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- Patients >= 65 years of age must have ECOG PS = = 50,000 blasts/uL; leukopheresis or hydroxyurea may be used immediately prior to study drug administration for cytoreduction; must be stopped 24 hours before first dose of study chemotherapy
- CBF AMLs associated with t(8;21) or M4eo subtype (inv[16] or t[16;16]), as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or FISH or molecular testing
- Acute Progranulocytic Leukemia (APL, M3)
- Active central nervous system (CNS) leukemia
- Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
- Active, uncontrolled graft vs. host disease (GVHD) following allogeneic transplant for non-AML condition (e.g. MDS, lymphoid malignancy, aplastic anemia); patients with GVHD controlled on stable doses of immunosuppressants are eligible
- Presence of other life-threatening illness
- Patients with mental deficits and/or psychiatric history that preclude them form giving informed consent or from following protocol
- Pregnant and nursing patients are excluded
Data sourced from ClinicalTrials.gov (NCT01349972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.