Phase 2
N=74
Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome · Adult Acute Megakaryoblastic Leukemia (M7) · Adult Acute Minimally Differentiated Myeloid Leukemia (M0) · Adult Acute Monoblastic Leukemia (M5a) · Adult Acute Monocytic Leukemia (M5b)
Bottom Line
View on ClinicalTrials.gov: NCT00795002 ↗Enrolled (actual)
74
Serious AEs
20.5%
Results posted
Dec 2013
Primary outcome: Primary: Complete Response — 24; 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alvocidib (Drug); mitoxantrone hydrochloride (Drug); cytarabine (Drug); pharmacological study (Other); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response |
24; 29 | — |
| SECONDARY Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM |
3; 3 | — |
| SECONDARY Disease-free Survival |
13.6; 12.0 | — |
Summary
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.
Eligibility Criteria
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 = = 45%
Data sourced from ClinicalTrials.gov (NCT00795002). 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.