Trial · NCT03012672

Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm

NCT03012672, Phase 2, Completed, University of Washington; results first posted 2021-11-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm. Trials, record NCT03012672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03012672

On this page

Trial

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

Title: Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm
NCT number: NCT03012672
Status: Completed
Phases: Phase 2
Enrollment: 50 participants, actual
Lead sponsor: University of Washington
Conditions: Acute Leukemia of Ambiguous Lineage, Acute Myeloid Leukemia, Myeloid Neoplasm
Interventions: Cladribine, Cytarabine, Granulocyte Colony-Stimulating Factor, Mitoxantrone Hydrochloride, Quality-of-Life Assessment, Questionnaire Administration
First posted: 2017-01-06
Last updated: 2022-03-08
Results first posted: 2021-11-01

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Feasibility Defined as Proportion of Patients Willing to be Randomized to Either Intensive or Non-intensive Induction and Post Remission Chemotherapy	At end of enrollment	Randomizing patients to either intensive or non-intensive induction and post remission chemotherapy will be considered feasible if the true proportion of patients willing to be randomized is 60% or higher.
Other	Event-free Survival	Up to 5 years	Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.
Other	Medical Complications	Up to 5 years	Information on medical complications (e.g. need for intensive care unit (ICU) level care, length of ICU stay, neutropenic fever, documented infections, bleeding, reasons for hospitalization) will be collected from the medical records from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA).
Other	Medical Resource Utilization	Up to 5 years	Information on use of medical resources (e.g. platelet transfusions; days of IV antimicrobial therapy, total hospital length of stay) will be collected from the medical records from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA).
Other	Overall Survival	Up to 5 years	Will be assessed for all patients. Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.
Other	Quality of Life as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30	Up to 12 months	Will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. Exploratory, descriptive, and observational methods will be used.
Other	Relapse-free Survival	Up to 5 years	Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.
Other	Response	Up to 5 years	The differences in anti-leukemic efficacy between patients treated with lower-intensity chemotherapy and those treated with higher-intensity chemotherapy will be estimated. Exploratory, descriptive, and observational methods will be used.
Other	Fitness for Intensive Chemotherapy as Measured by a Treatment-related Mortality (TRM) Score That Includes Additional Co-morbidity Factors	Up to 12 months	The ability of physicians and the prediction algorithm(s) to assess the likelihood of early death will be compared.
Other	Duration of Response	Up to 5 years	Will be evaluated.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Feasibility Defined as Proportion of Patients Willing to be Randomized to Either Intensive or Non-intensive Induction and Post Remission Chemotherapy	At end of enrollment	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Event-free Survival	Up to 5 years
OTHER_PRE_SPECIFIED	Medical Complications	Up to 5 years
OTHER_PRE_SPECIFIED	Medical Resource Utilization	Up to 5 years
OTHER_PRE_SPECIFIED	Overall Survival	Up to 5 years
OTHER_PRE_SPECIFIED	Quality of Life as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30	Up to 12 months
OTHER_PRE_SPECIFIED	Relapse-free Survival	Up to 5 years
OTHER_PRE_SPECIFIED	Response	Up to 5 years
OTHER_PRE_SPECIFIED	Fitness for Intensive Chemotherapy as Measured by a Treatment-related Mortality (TRM) Score That Includes Additional Co-morbidity Factors	Up to 12 months
OTHER_PRE_SPECIFIED	Duration of Response	Up to 5 years

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Feasibility Defined as Proportion of Patients Willing to be Randomized to Either Intensive or Non-intensive Induction and Post Remission Chemotherapy	All Patients Enrolled	Patients/physician pairs agreed to be randomized	3		Participants
Feasibility Defined as Proportion of Patients Willing to be Randomized to Either Intensive or Non-intensive Induction and Post Remission Chemotherapy	All Patients Enrolled	Patients/physician pairs not agreed to be randomized	47		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Higher-dose)	20
Overall Study	STARTED	Arm II (Lower-dose)	30
Overall Study	COMPLETED	Arm I (Higher-dose)	20
Overall Study	COMPLETED	Arm II (Lower-dose)	30
Overall Study	NOT COMPLETED	Arm I (Higher-dose)	0
Overall Study	NOT COMPLETED	Arm II (Lower-dose)	0

Source ClinicalTrials.gov

Adverse events120

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	Acute Kidney Injury	Renal and urinary disorders	ARM I (HIGHER-DOSE):	1	20	2
other	Acute Kidney Injury	Renal and urinary disorders	ARM II (LOWER-DOSE):	2	30	2
other	Alkalosis	Metabolism and nutrition disorders	ARM I (HIGHER-DOSE):	1	20	1
other	Alkalosis	Metabolism and nutrition disorders	ARM II (LOWER-DOSE):	0	30	0
other	Anorexia	Metabolism and nutrition disorders	ARM I (HIGHER-DOSE):	1	20	1
other	Anorexia	Metabolism and nutrition disorders	ARM II (LOWER-DOSE):	1	30	1
other	Atrial Fibrillation	Cardiac disorders	ARM I (HIGHER-DOSE):	2	20	3
other	Atrial Fibrillation	Cardiac disorders	ARM II (LOWER-DOSE):	1	30	1
other	Bacteremia	Infections and infestations	ARM I (HIGHER-DOSE):	5	20	5
other	Bacteremia	Infections and infestations	ARM II (LOWER-DOSE):	4	30	6

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ARM I (HIGHER-DOSE):	16	20
Total, all-cause mortality	ARM II (LOWER-DOSE):	25	30
Total, other adverse events	ARM I (HIGHER-DOSE):	16	20
Total, other adverse events	ARM II (LOWER-DOSE):	30	30
Total, serious adverse events	ARM I (HIGHER-DOSE):	9	20
Total, serious adverse events	ARM II (LOWER-DOSE):	14	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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
P30CA015704	Cancer Center Support Grant	LYNCH, THOMAS JAMES	FRED HUTCHINSON CANCER CENTER	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
ARM I (HIGHER-DOSE): vs ARM II (LOWER-DOSE):: deaths from any cause	Trial comparisons
ARM I (HIGHER-DOSE): vs ARM II (LOWER-DOSE):: 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/NCT03012672

GET https://conductscience.org/api/trials/v1/NCT03012672/events?page=2

API reference For AI assistants