Trial · NCT01349972

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

NCT01349972, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT01349972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01349972

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT number: NCT01349972
Status: Completed
Phases: Phase 2
Enrollment: 172 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: 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), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Interventions: alvocidib, daunorubicin hydrochloride, mitoxantrone hydrochloride, cytarabine
First posted: 2011-05-09
Last updated: 2017-07-31
Results first posted: 2017-06-06

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Response Rate	3 years	Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/cu mm and a platelet count of 100,000/cu mm, 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. These criteria are taken from Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010;115:453-474
Secondary	Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade	Up to 14 days after completion of study treatment	The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Secondary	Disease-free Survival	Time from randomization until death from any cause or relapse or recurrence, assessed up to 2 years	Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated. Disease-free survival Overall survival was defined from date of randomization to death or last known follow-up. Event free survival was defined as date of randomization to the first occurrence of persistent AML after 1 cycle of induction, relapse or death. Patients were censored for event free survival if they had received non-protocol therapy or a stem cell transplant.
Secondary	Overall Survival	4 years	Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.
Secondary	Number of Patients With Minimal Residual Disease	From study start to 14 days after the start of treatment	Comparisons of the treatments with respect to MRD will be based on the number of patients with MRD at day 14 after the start of treatment.
Secondary	Progression-free Survival	4 years	Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Response Rate	3 years		participants	NUMBER
SECONDARY	Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade	Up to 14 days after completion of study treatment	Number of evaluable subjects	Number of events	NUMBER
SECONDARY	Disease-free Survival	Time from randomization until death from any cause or relapse or recurrence, assessed up to 2 years		years	MEDIAN
SECONDARY	Overall Survival	4 years		years	MEDIAN
SECONDARY	Number of Patients With Minimal Residual Disease	From study start to 14 days after the start of treatment		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival	4 years		years	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Complete Response Rate	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	76		participants
Complete Response Rate	Arm II (Cytarabine, Daunorubicin Hydrochloride)	24		participants
Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	156		Number of events
Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade	Arm II (Cytarabine, Daunorubicin Hydrochloride)	77		Number of events
Disease-free Survival	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	1.46	Full Range 1.06 to 2.11	years
Disease-free Survival	Arm II (Cytarabine, Daunorubicin Hydrochloride)	1.85	Full Range 1.35 to 3.33	years
Overall Survival	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	1.46	95% Confidence Interval 0.09 to 2.12	years
Overall Survival	Arm II (Cytarabine, Daunorubicin Hydrochloride)	1.850	95% Confidence Interval 1.35 to 3.33	years
Number of Patients With Minimal Residual Disease	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	26		Participants
Number of Patients With Minimal Residual Disease	Arm II (Cytarabine, Daunorubicin Hydrochloride)	24		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	114
Overall Study	STARTED	Arm II (Cytarabine, Daunorubicin Hydrochloride)	58
Overall Study	COMPLETED	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	109
Overall Study	COMPLETED	Arm II (Cytarabine, Daunorubicin Hydrochloride)	56
Overall Study	NOT COMPLETED	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	5
Overall Study	NOT COMPLETED	Arm II (Cytarabine, Daunorubicin Hydrochloride)	2

Source ClinicalTrials.gov

Adverse events156

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Febril eNeutropenia	Blood and lymphatic system disorders	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	5	114	5
other	Febril eNeutropenia	Blood and lymphatic system disorders	Arm II (Cytarabine, Daunorubicin Hydrochloride)	7	58	7
other	Sepsis	Infections and infestations	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	4	114	4
other	Sepsis	Infections and infestations	Arm II (Cytarabine, Daunorubicin Hydrochloride)	1	58	1
other	Catheter Related Infection	Infections and infestations	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	0	114	0
other	Catheter Related Infection	Infections and infestations	Arm II (Cytarabine, Daunorubicin Hydrochloride)	1	58	1
other	Bacteremia	Infections and infestations	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	2	114	2
other	Bacteremia	Infections and infestations	Arm II (Cytarabine, Daunorubicin Hydrochloride)	0	58	0
other	Pneumonia	Infections and infestations	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	0	114	0
other	Pneumonia	Infections and infestations	Arm II (Cytarabine, Daunorubicin Hydrochloride)	1	58	1

1 to 10 of 156Source ClinicalTrials.gov

See all 156 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
Total, all-cause mortality	Arm II (Cytarabine, Daunorubicin Hydrochloride)
Total, other adverse events	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	32	114
Total, other adverse events	Arm II (Cytarabine, Daunorubicin Hydrochloride)	21	58
Total, serious adverse events	Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)	53	114
Total, serious adverse events	Arm II (Cytarabine, Daunorubicin Hydrochloride)	21	58

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26022709	RESULT	PubMed
26819054	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
P30CA006973	Regional Oncology Research Center	NELSON, WILLIAM GEORGE	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2025	NIH RePORTER
U01CA070095	Phase I Clinical Trials of New Anti-Cancer Targeted Therapies	CARDUCCI, MICHAEL A	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	1995 to 2013	NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride) vs Arm II (Cytarabine, Daunorubicin Hydrochloride): Number of Patients With Minimal Residual Disease	Trial comparisons
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride) vs Arm II (Cytarabine, Daunorubicin Hydrochloride): Complete Response Rate	Trial comparisons
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride) vs Arm II (Cytarabine, Daunorubicin Hydrochloride): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01349972

GET https://conductscience.org/api/trials/v1/NCT01349972/events?page=2

API reference For AI assistants