Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm

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ClinicalTrials.gov Identifier: NCT01101880

Recruitment Status : Completed

First Posted : April 12, 2010

Results First Posted : October 19, 2017

Last Update Posted : October 19, 2017

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Pamela S Becker, University of Washington

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	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(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Refractory Anemia With Excess Blasts Untreated Adult Acute Myeloid Leukemia Myeloproliferative Neoplasm With 10% Blasts or Higher
Interventions	Biological: filgrastim Drug: clofarabine Drug: cytarabine
Enrollment	50

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description	INDUCTION THERAPY: Patients receive...
Arm/Group Description	INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Period Title: Overall Study
Started	50
Completed	50
Not Completed	0

Baseline Characteristics

Arm/Group Title		Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description		INDUCTION THERAPY: Patients receive...
Arm/Group Description		INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Overall Number of Baseline Participants		50
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	50 participants
		53 (22 to 64)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants
	Female	23 46.0%
	Male	27 54.0%
Cytogenetic Risk Factor Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants
	Favorable	4 8.0%
	Intermediate	32 64.0%
	Unfavorable	13 26.0%
	Indeterminate	1 2.0%
Antecedent hematological disorder (AHD) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants
		23 46.0%
FLT3 ITD mutation status ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants
		10 20.0%
		[1] Measure Description: Number of participants with a FLT3 ITD mutation
WBC Median (Full Range) Unit of measure: Cells x 10^9/L
	Number Analyzed	50 participants
		12 (0.8 to 761.3)
Peripheral Blast Median (Full Range) Unit of measure: Percent of white blood cells
	Number Analyzed	50 participants
		16 (0 to 100)

Outcome Measures

1.Primary Outcome


Title	Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts
Description	With 50 patients, the rates of these endpoints will be estimated with ...
Description	With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

CR achieved with no AHD only applies to those who did not have AHD.


Arm/Group Title		Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description:		INDUCTION THERAPY: Patients receive...
Arm/Group Description:		INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Overall Number of Participants Analyzed		50
Measure Type: Count of Participants Unit of Measure: Participants
CR achieved	Number Analyzed	50 participants
CR achieved		38 76.0%
CR achieved with first course of induction	Number Analyzed	50 participants
CR achieved with first course of induction		33 66.0%
CR + CRp achieved	Number Analyzed	50 participants
CR + CRp achieved		41 82.0%
CR achieved with no AHD	Number Analyzed	27 participants
CR achieved with no AHD		23 85.2%
CR achieved with AHD	Number Analyzed	23 participants
CR achieved with AHD		15 65.2%
CR + CRp achieved with AHD	Number Analyzed	23 participants
CR + CRp achieved with AHD		18 78.3%
CR achieved with FLT3 positive	Number Analyzed	10 participants
CR achieved with FLT3 positive		7 70.0%
CR achieved with favorable risk cytogenetics	Number Analyzed	4 participants
CR achieved with favorable risk cytogenetics		4 100.0%
CR achieved with intermediate risk cytogenetics	Number Analyzed	32 participants
CR achieved with intermediate risk cytogenetics		26 81.3%
CR + CRp achieved with intermediate risk cyto.	Number Analyzed	32 participants
CR + CRp achieved with intermediate risk cyto.		27 84.4%
CR achieved with unfavorable risk cytogenetics	Number Analyzed	13 participants
CR achieved with unfavorable risk cytogenetics		8 61.5%
CR + CRp achieved with unfavorable risk cyto.	Number Analyzed	13 participants
CR + CRp achieved with unfavorable risk cyto.		10 76.9%

2.Primary Outcome


Title	Duration of Remission
Description	With 50 patients, the rates of these endpoints will be estimated with ...
Description	With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Remission is defined as less than 5% blasts in the bone marrow, no appearance of blasts in the peripheral blood, and no extramedullary disease (appearance of leukemic cells in other tissues).
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description:	INDUCTION THERAPY: Patients receive...
Arm/Group Description:	INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Overall Number of Participants Analyzed	9
Median (Full Range) Unit of Measure: weeks
	7 (4 to 84)

3.Primary Outcome


Title	Time to Progression
Description	With 50 patients, the rates of these endpoints will be estimated with ...
Description	With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description:	INDUCTION THERAPY: Patients receive...
Arm/Group Description:	INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Overall Number of Participants Analyzed	9
Median (Full Range) Unit of Measure: weeks
	7 (4 to 84)

4.Primary Outcome


Title	Event Free Survival
Description	Number of patients in remission at a median follow up of 15 months.
Description	Number of patients in remission at a median follow up of 15 months.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description:	INDUCTION THERAPY: Patients receive...
Arm/Group Description:	INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Overall Number of Participants Analyzed	50
Measure Type: Count of Participants Unit of Measure: Participants
	21 42.0%

5.Primary Outcome


Title	Treatment-related Mortality (TRM)
Description	Treatment-related mortality (TRM) data was not collected.
Description	Treatment-related mortality (TRM) data was not collected.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Treatment-related mortality (TRM) data was not collected.


Arm/Group Title	Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description:	INDUCTION THERAPY: Patients receive...
Arm/Group Description:	INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

6.Primary Outcome


Title	Overall Survival
Description	With 50 patients, the rates of these endpoints will be estimated with ...
Description	With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description:	INDUCTION THERAPY: Patients receive...
Arm/Group Description:	INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
Overall Number of Participants Analyzed	50
Median (95% Confidence Interval) Unit of Measure: months
	24.3 (15 to 60)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Other [Not including Serious] Adverse Events were not monitored/assessed.

Arm/Group Title	Treatment (Chemotherapy and Colony Stimulating Factor)
Arm/Group Description	INDUCTION THERAPY: Patients receive...
Arm/Group Description	INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
All-Cause Mortality
	Treatment (Chemotherapy and Colony Stimulating Factor)
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Treatment (Chemotherapy and Colony Stimulating Factor)
	Affected / at Risk (%)	# Events
Total	50/50 (100.00%)
Blood and lymphatic system disorders
Coagulation ^†	4/50 (8.00%)	4
Cardiac disorders
Cardiovascular ^†	2/50 (4.00%)	2
Eye disorders
Ocular ^†	1/50 (2.00%)	1
Gastrointestinal disorders
Gastrointestinal ^†	10/50 (20.00%)	10
General disorders
Pain ^†	1/50 (2.00%)	1
Hepatobiliary disorders
Liver enzymes ^†	20/50 (40.00%)	20
Hepatobiliary ^†	1/50 (2.00%)	1
Infections and infestations
infection ^†	50/50 (100.00%)	95
Metabolism and nutrition disorders
Metabolic ^†	10/50 (20.00%)	10
Nervous system disorders
Neurologic ^†	6/50 (12.00%)	6
Renal and urinary disorders
Urinary ^†	1/50 (2.00%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary ^†	31/50 (62.00%)	31
Skin and subcutaneous tissue disorders
Dermatologic ^†	10/50 (20.00%)	10
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment (Chemotherapy and Colony Stimulating Factor)
	Affected / at Risk (%)	# Events
Total	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Pamela Becker, MD, PhD
Organization:	University of Washington
Phone:	206-288-7273
EMail:	pbecker@uw.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Becker PS, Medeiros BC, Stein AS, Othus M, Appelbaum FR, Forman SJ, Scott BL, Hendrie PC, Gardner KM, Pagel JM, Walter RB, Parks C, Wood BL, Abkowitz JL, Estey EH. G-CSF priming, clofarabine, and high dose cytarabine (GCLAC) for upfront treatment of acute myeloid leukemia, advanced myelodysplastic syndrome or advanced myeloproliferative neoplasm. Am J Hematol. 2015 Apr;90(4):295-300. doi: 10.1002/ajh.23927. Epub 2015 Jan 30.

Layout table for additonal information

Responsible Party:	Pamela S Becker, University of Washington
ClinicalTrials.gov Identifier:	NCT01101880
Other Study ID Numbers:	7144 NCI-2010-00282 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted:	April 8, 2010
First Posted:	April 12, 2010
Results First Submitted:	March 4, 2017
Results First Posted:	October 19, 2017
Last Update Posted:	October 19, 2017

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