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

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ClinicalTrials.gov Identifier: NCT00407966
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : February 11, 2013
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
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 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 Drug: alvocidib
Drug: cytarabine
Drug: mitoxantrone hydrochloride
Enrollment 45
Recruitment Details From December 2006 through June 2008
Pre-assignment Details  
Arm/Group Title Arm A
Hide Arm/Group Description Flavopiridol, ara-C, mitoxantrone
Period Title: Overall Study
Started 45
CR 30
Completed 45
Not Completed 0
Arm/Group Title Arm A
Hide Arm/Group Description Flavopiridol, ara-C, mitoxantrone
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  71.1%
>=65 years
13
  28.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
61  (50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
22
  48.9%
Male
23
  51.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
1.Primary Outcome
Title Complete Response
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of participants entered between December 2006 and June 2008
Arm/Group Title Arm A
Hide Arm/Group Description:
Flavopiridol, ara-C, mitoxantrone
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
45
Time Frame Adverse events were collected from the time of treatmetn through recovery of blood counts and response assessment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A
Hide Arm/Group Description Flavopiridol, ara-C, mitoxantrone
All-Cause Mortality
Arm A
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A
Affected / at Risk (%) # Events
Total   19/45 (42.22%)    
Cardiac disorders   
cardiac dysfunction   7/45 (15.56%)  7
Investigations   
Desseminated Intravascular Coagulopathy   3/45 (6.67%)  3
Metabolism and nutrition disorders   
Tumor lysis syndrome   19/45 (42.22%)  19
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A
Affected / at Risk (%) # Events
Total   25/45 (55.56%)    
Gastrointestinal disorders   
oral mucositis   14/45 (31.11%)  14
Diarrhea  1  11/45 (24.44%)  11
GI Mucositis   5/45 (11.11%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Judith Karp, MD
Organization: SKCCC
Phone: 410-502-7726
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00407966     History of Changes
Other Study ID Numbers: NCI-2012-02986
NCI-2012-02986 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U01CA070095 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
J0669 ( Other Identifier: Johns Hopkins University/Sidney Kimmel Cancer Center )
7845 ( Other Identifier: CTEP )
First Submitted: December 4, 2006
First Posted: December 5, 2006
Results First Submitted: May 1, 2012
Results First Posted: February 11, 2013
Last Update Posted: August 4, 2015