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Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00096122
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : July 15, 2011
Last Update Posted : May 26, 2014
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)
Childhood Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Refractory Anemia With Excess Blasts
Refractory Anemia With Excess Blasts in Transformation
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: cytarabine
Drug: idarubicin
Drug: tipifarnib
Enrollment 95

Recruitment Details Recruitment Period: 9/16/2004 to 9/22/2006. All patients registered at The University of Texas M.D. Anderson Cancer Center.
Pre-assignment Details One participant enrolled was excluded from the study.
Arm/Group Title Idarubicin, Cytarabine + Tipifarnib
Hide Arm/Group Description Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Period Title: Overall Study
Started 95
Completed 95
Not Completed 0
Arm/Group Title Idarubicin, Cytarabine + Tipifarnib
Hide Arm/Group Description Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Overall Number of Baseline Participants 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 95 participants
50
(17 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants
Female
53
  55.8%
Male
42
  44.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 95 participants
95
1.Primary Outcome
Title Number of Participants With Complete Response
Hide Description Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1*10^9/L or more and platelet count of 100*10^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20*10^9/L to less than 100*10^9/L.
Time Frame 21 Day Cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol.
Arm/Group Title Idarubicin, Cytarabine + Tipifarnib
Hide Arm/Group Description:
Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
Overall Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: Participants
CR 61
CRp 9
Time Frame 5 years 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Idarubicin, Cytarabine + Tipifarnib
Hide Arm/Group Description Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
All-Cause Mortality
Idarubicin, Cytarabine + Tipifarnib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Idarubicin, Cytarabine + Tipifarnib
Affected / at Risk (%) # Events
Total   46/95 (48.42%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/95 (1.05%)  1
Cardiac disorders   
Decreased left ventricular ejection fraction (LVEF)  1  1/95 (1.05%)  1
Gastrointestinal disorders   
Enteritis  1  1/95 (1.05%)  1
Typhilitis  1  1/95 (1.05%)  1
Ileus  1  1/95 (1.05%)  1
Esophagitis  1  1/95 (1.05%)  1
Colitis  1  2/95 (2.11%)  2
Nausea  1  1/95 (1.05%)  1
Vomiting  1  1/95 (1.05%)  1
Diarrhea  1  2/95 (2.11%)  2
General disorders   
Death  1  5/95 (5.26%)  5
Edema  1  1/95 (1.05%)  1
Pain  1  1/95 (1.05%)  1
Hepatobiliary disorders   
Hyperbilirubinemia  1  6/95 (6.32%)  6
Infections and infestations   
Infection  1  12/95 (12.63%)  14
Febrile neutropenia  1  14/95 (14.74%)  21
Metabolism and nutrition disorders   
Hypokalemia  1  2/95 (2.11%)  2
Nervous system disorders   
Cognitive disturbance  1  1/95 (1.05%)  1
Seizure  1  1/95 (1.05%)  1
Confusion  1  1/95 (1.05%)  1
Renal and urinary disorders   
Renal Failure  1  1/95 (1.05%)  1
Respiratory, thoracic and mediastinal disorders   
Bilateral pleural effusions  1  1/95 (1.05%)  1
Respiratory Failure  1  1/95 (1.05%)  1
Vascular disorders   
Hemorrhage  1  5/95 (5.26%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idarubicin, Cytarabine + Tipifarnib
Affected / at Risk (%) # Events
Total   95/95 (100.00%)    
Cardiac disorders   
Hypotension  1  12/95 (12.63%)  12
Gastrointestinal disorders   
Diarrhea  1  66/95 (69.47%)  66
Nausea/Vomiting  1  54/95 (56.84%)  54
Mucositis  1  23/95 (24.21%)  23
Constipation  1  11/95 (11.58%)  11
Anorexia  1  8/95 (8.42%)  8
General disorders   
Pain  1  27/95 (28.42%)  27
Fatigue  1  20/95 (21.05%)  20
Edema  1  11/95 (11.58%)  11
Hepatobiliary disorders   
Hyperbilirubinemia  1  25/95 (26.32%)  25
Metabolism and nutrition disorders   
Hypokalemia  1  12/95 (12.63%)  12
Hypoalbuminemia  1  10/95 (10.53%)  10
Hyperglycemia  1  10/95 (10.53%)  10
Hypophosphatemia  1  8/95 (8.42%)  8
Hypocalcemia  1  6/95 (6.32%)  6
Nervous system disorders   
Mood alteration  1  12/95 (12.63%)  12
Renal and urinary disorders   
Elevated creatinine  1  7/95 (7.37%)  7
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  9/95 (9.47%)  9
Skin and subcutaneous tissue disorders   
Rash/Puritis  1  51/95 (53.68%)  51
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Jorge Cortes, MD / Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-745-5783
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096122     History of Changes
Other Study ID Numbers: NCI-2012-02862
2003-0563
6625
N01CM62202 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: June 13, 2011
Results First Posted: July 15, 2011
Last Update Posted: May 26, 2014