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Trial record 35 of 188 for:    "Acute megakaryoblastic leukemia"

Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS

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ClinicalTrials.gov Identifier: NCT01607645
Recruitment Status : Terminated (The study was terminated early because there were other competing protocols.)
First Posted : May 30, 2012
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Derek Stirewalt, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Megakaryoblastic Leukemia (M7)
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)
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts
Interventions Drug: decitabine
Drug: idarubicin
Drug: cytarabine
Enrollment 7
Recruitment Details Participant were enrolled between 8/23/12 and 5/16/13 at the FHCRC
Pre-assignment Details  
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) Total
Hide Arm/Group Description

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
50.75  (16.46) 34.67  (13.01) 43.86  (16.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
2
  50.0%
2
  66.7%
4
  57.1%
Male
2
  50.0%
1
  33.3%
3
  42.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
3
 100.0%
7
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  33.3%
1
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
2
  66.7%
6
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Number of Participants Who Achieved Morphologic CR
Hide Description Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, <5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease
Time Frame Participants were monitored up until the point when they went off study following completion of the treatment (3 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: participants
CR 2 0
CRi-MRD (Minimal Residual Disease) 1 0
Refractory 1 3
2.Secondary Outcome
Title Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM
Hide Description [Not Specified]
Time Frame Assessed for up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
3
 100.0%
3.Secondary Outcome
Title Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
0
   0.0%
4.Secondary Outcome
Title CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
0
   0.0%
5.Secondary Outcome
Title CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
0
   0.0%
8.Secondary Outcome
Title TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine
Hide Description [Not Specified]
Time Frame Assessed for up to Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0
Hide Description [Not Specified]
Time Frame Assessed for up to 3 months after completion study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We have analyzed 4 and 3 patients in each arm, respectively. One patient in each of the arms completed 2 cycles of therapy. The numbers provided in the Outcome Measure Data Table in Frequency and Severity of Grade 3, 4, and 5 Toxicities are the numbers of patients with each specified event.
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
CYCLE 1 : Infection Grade 3 Number Analyzed 4 participants 3 participants
2
  50.0%
0
   0.0%
CYCLE 1 : Infection Grade 4 Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
CYCLE 1 : Hepatobiliary Grade 3 Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
CYCLE 1 : Blood and Lymphatic Grade 3 Number Analyzed 4 participants 3 participants
3
  75.0%
1
  33.3%
CYCLE 1 : Gastrointenstinal Grade 3 Number Analyzed 4 participants 3 participants
0
   0.0%
0
   0.0%
CYCLE 2 : Infection Grade 3 Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
CYCLE 2 : Infection Grade 4 Number Analyzed 4 participants 3 participants
0
   0.0%
0
   0.0%
CYCLE 2 : Hepatobiliary Grade 3 Number Analyzed 4 participants 3 participants
0
   0.0%
0
   0.0%
CYCLE 2 : Blood and Lymphatic Grade 3 Number Analyzed 4 participants 3 participants
1
  25.0%
0
   0.0%
CYCLE 2 : Gastrointenstinal Grade 3 Number Analyzed 4 participants 3 participants
1
  25.0%
0
   0.0%
10.Secondary Outcome
Title Severe Prolonged Aplasia
Hide Description [Not Specified]
Time Frame Assessed for up to 45 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Duration of Severe Neutropenia Defined as an ANC Less Than 500
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 3 0
Mean (Full Range)
Unit of Measure: days
65
(25 to 106)
12.Secondary Outcome
Title Duration of Moderate Neutropenia Defined as an ANC Less Than 1000
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 3 0
Mean (Full Range)
Unit of Measure: days
67
(30 to 106)
13.Secondary Outcome
Title Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000
Hide Description [Not Specified]
Time Frame Assessed for up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description:

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Overall Number of Participants Analyzed 3 0
Mean (Full Range)
Unit of Measure: days
51
(18 to 103)
Time Frame The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Hide Arm/Group Description

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

All-Cause Mortality
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      1/3 (33.33%)    
Infections and infestations     
Grade 4 Infection * [1]  0/4 (0.00%)  0 1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Patient became septic with coag negative Staphylococcus, requiring prolonged hospitalization and IV antibiotics with blood pressure support
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      2/3 (66.67%)    
Blood and lymphatic system disorders     
Febrile Neutropenia * [1]  2/4 (50.00%)  2 2/3 (66.67%)  2
Gastrointestinal disorders     
Abdominal Pain * [2]  1/4 (25.00%)  1 0/3 (0.00%)  0
Hemorrhoids * [3]  2/4 (50.00%)  2 0/3 (0.00%)  0
Diarrhea * [4]  1/4 (25.00%)  1 0/3 (0.00%)  0
Hepatobiliary disorders     
Hyperbilirubinemia * [5]  1/4 (25.00%)  1 2/3 (66.67%)  2
Infections and infestations     
Infection * [6]  2/4 (50.00%)  5 0/3 (0.00%)  0
Reproductive system and breast disorders     
Menorrhagia * [7]  1/4 (25.00%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Joint pain * [8]  0/4 (0.00%)  0 1/3 (33.33%)  1
Back Pain * [9]  1/4 (25.00%)  1 0/3 (0.00%)  0
Vascular disorders     
Venous thrombosis * [10]  1/4 (25.00%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Expected Grade 3 febrile neutropenia
[2]
Grade 2 abdominal pain
[3]
Grade 1 hemorrhoids
[4]
Grade 2 diarrhea
[5]
One patient with Grade 1; one patient with Grade 2; one patient with Grade 3
[6]
2 patients with grade 3 C. difficle; 1 patient with Grade 3 UTI; 1 patient with Grade 3 device related infection; 1 patient with Grade 3 lung infection
[7]
One patient developed Grade 2 menorrhagia
[8]
Patient developed both, Grade 2 elbow and knee pain
[9]
Patient developed Grade 1 back pain
[10]
One patient developed Grade 2 thrombotic event
Early termination due to similar competing protocol, which made statistical evaluation of primary endpoint and any meaningful evaluation of secondary time points not feasible.
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
Name/Title: Derek L. Stirewalt
Organization: FHCRC
Phone: 2066675386
Responsible Party: Derek Stirewalt, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01607645     History of Changes
Other Study ID Numbers: 2588.00
NCI-2012-00769 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2012
First Posted: May 30, 2012
Results First Submitted: October 13, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017