Trial · NCT00703820

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

NCT00703820, Phase 3, Completed, St. Jude Children's Research Hospital; results first posted 2018-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT00703820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703820

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Trial

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

Title: Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
NCT number: NCT00703820
Status: Completed
Phases: Phase 3
Enrollment: 324 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Acute Myeloid Leukemia
Interventions: Cytarabine, Daunorubicin, Etoposide, Clofarabine, CliniMACS
First posted: 2008-06-24
Last updated: 2021-08-10
Results first posted: 2018-04-02

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry	Day 22 MRD measurement after one course of therapy	MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
Secondary	Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.	3 years after completion of therapy	Kaplan-Meier estimate of the probability of being alive and free of relapse or second malignancy three years after protocol enrollment
Secondary	Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.	3 years after completion of therapy	Kaplan-Meier estimate of the probability of being alive and free of relapse or second malignancy three years after protocol enrollment

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry	Day 22 MRD measurement after one course of therapy	Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.	3 years after completion of therapy	Randomized standard risk patients who received chemotherapy only	Percentage of participants	NUMBER
SECONDARY	Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.	3 years after completion of therapy	Randomized patients who received NK cell therapy after chemotherapy	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry	Cytarabine+Daunorubicin+Etoposide	MRD Positive	42		Participants
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry	Clofarabine+Cytarabine	MRD Positive	57		Participants
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry	Cytarabine+Daunorubicin+Etoposide	MRD Negative	79		Participants
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry	Clofarabine+Cytarabine	MRD Negative	64		Participants
Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.	Cytarabine+Daunorubicin+Etoposide		55.6	95% Confidence Interval 43.3 to 71.4	Percentage of participants
Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.	Clofarabine+Cytarabine		54.3	95% Confidence Interval 40.6 to 72.5	Percentage of participants
Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.	Cytarabine+Daunorubicin+Etoposide		55.6	95% Confidence Interval 31.0 to 99.7	Percentage of participants
Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.	Clofarabine+Cytarabine		77.8	95% Confidence Interval 54.9 to 100.0	Percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cytarabine+Daunorubicin+Etoposide	133
Overall Study	STARTED	Clofarabine+Cytarabine	129
Overall Study	COMPLETED	Cytarabine+Daunorubicin+Etoposide	98
Overall Study	COMPLETED	Clofarabine+Cytarabine	95
Overall Study	NOT COMPLETED	Cytarabine+Daunorubicin+Etoposide	35
Overall Study	NOT COMPLETED	Clofarabine+Cytarabine	34

Source ClinicalTrials.gov

Adverse events534

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	Allergic reaction/hypersensitivity (including drug fever)	Immune system disorders	Cytarabine+Daunorubicin+Etoposide	9	133	11
other	Allergic reaction/hypersensitivity (including drug fever)	Immune system disorders	Clofarabine+Cytarabine	9	129	10
other	Allergic reaction/hypersensitivity (including drug fever)	Immune system disorders	Stem Cell Donors	0	29	0
serious	ALT, SGPT (serum glutamic pyruvic transaminase)	Metabolism and nutrition disorders	Cytarabine+Daunorubicin+Etoposide	33	133	47
serious	ALT, SGPT (serum glutamic pyruvic transaminase)	Metabolism and nutrition disorders	Clofarabine+Cytarabine	48	129	62
serious	ALT, SGPT (serum glutamic pyruvic transaminase)	Metabolism and nutrition disorders	Stem Cell Donors	0	29	0
serious	Potassium, serum-low (hypokalemia)	Metabolism and nutrition disorders	Cytarabine+Daunorubicin+Etoposide	45	133	78
serious	Potassium, serum-low (hypokalemia)	Metabolism and nutrition disorders	Clofarabine+Cytarabine	48	129	90
serious	Potassium, serum-low (hypokalemia)	Metabolism and nutrition disorders	Stem Cell Donors	0	29	0
serious	AST, SGOT (serum glutamic oxaloacetic transaminase)	Metabolism and nutrition disorders	Cytarabine+Daunorubicin+Etoposide	20	133	26

1 to 10 of 534Source ClinicalTrials.gov

See all 534 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cytarabine+Daunorubicin+Etoposide	43	133
Total, all-cause mortality	Clofarabine+Cytarabine	32	129
Total, all-cause mortality	Stem Cell Donors	0	29
Total, other adverse events	Cytarabine+Daunorubicin+Etoposide	9	133
Total, other adverse events	Clofarabine+Cytarabine	9	129
Total, other adverse events	Stem Cell Donors	0	29
Total, serious adverse events	Cytarabine+Daunorubicin+Etoposide	127	133
Total, serious adverse events	Clofarabine+Cytarabine	122	129
Total, serious adverse events	Stem Cell Donors	0	29

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30894213	DERIVED	PubMed
31246522	DERIVED	PubMed

Grants3

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
R01CA132946	Genomics of AML Prognosis	LAMBA, JATINDER K.; POUNDS, STANLEY BARRETT	UNIVERSITY OF FLORIDA	NATIONAL CANCER INSTITUTE	2008 to 2025	NIH RePORTER
R01CA138744	Tyrosine kinase inhibitors for the treatment of childhood AML	BAKER, SHARYN D	OHIO STATE UNIVERSITY	NATIONAL CANCER INSTITUTE	2010 to 2019	NIH RePORTER
R01CA115422	Clinical Significance of Residual Myeloid Leukemia	CAMPANA, DARIO	ST. JUDE CHILDREN'S RESEARCH HOSPITAL	NATIONAL CANCER INSTITUTE	2006 to 2010	NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT00703820

GET https://conductscience.org/api/trials/v1/NCT00703820/events?page=2

API reference For AI assistants