Trial Outcomes & Findings for Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT00407966)

Results Overview

Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an Absolute Neutrophil Count of at least 1000/mililiter and a platelet count of 100,000 mililiter, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A complete remission must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the complete remission.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

6 months

Results posted on

2015-08-04

Participant Flow

From December 2006 through June 2008

Participant milestones

Participant milestones
Measure	Arm A Flavopiridol, ara-C, mitoxantrone
Overall Study STARTED	45
Overall Study CR	30
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=45 Participants Flavopiridol, ara-C, mitoxantrone
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 50 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Total number of participants entered between December 2006 and June 2008

Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an Absolute Neutrophil Count of at least 1000/mililiter and a platelet count of 100,000 mililiter, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A complete remission must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the complete remission.

Outcome measures

Outcome measures
Measure	Arm A n=45 Participants Flavopiridol, ara-C, mitoxantrone
Complete Response	45 participants

Adverse Events

Arm A

Serious events: 19 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=45 participants at risk Flavopiridol, ara-C, mitoxantrone
Metabolism and nutrition disorders Tumor lysis syndrome	42.2% 19/45 • Number of events 19 • Adverse events were collected from the time of treatmetn through recovery of blood counts and response assessment
Cardiac disorders cardiac dysfunction	15.6% 7/45 • Number of events 7 • Adverse events were collected from the time of treatmetn through recovery of blood counts and response assessment
Investigations Desseminated Intravascular Coagulopathy	6.7% 3/45 • Number of events 3 • Adverse events were collected from the time of treatmetn through recovery of blood counts and response assessment

Other adverse events

Other adverse events
Measure	Arm A n=45 participants at risk Flavopiridol, ara-C, mitoxantrone
Gastrointestinal disorders oral mucositis	31.1% 14/45 • Number of events 14 • Adverse events were collected from the time of treatmetn through recovery of blood counts and response assessment
Gastrointestinal disorders Diarrhea	24.4% 11/45 • Number of events 11 • Adverse events were collected from the time of treatmetn through recovery of blood counts and response assessment
Gastrointestinal disorders GI Mucositis	11.1% 5/45 • Number of events 5 • Adverse events were collected from the time of treatmetn through recovery of blood counts and response assessment

Additional Information

Judith Karp, MD

SKCCC

Phone: 410-502-7726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60