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Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission

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ClinicalTrials.gov Identifier: NCT01465386
Recruitment Status : Terminated (Closed early due to slow enrollment)
First Posted : November 4, 2011
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Promyelocytic Leukemia (M3)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Intervention Drug: bortezomib
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treated Patients
Hide Arm/Group Description

Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

bortezomib: Given SC

Period Title: Overall Study
Started 6
Completed 2
Not Completed 4
Reason Not Completed
Lack of Efficacy             3
Adverse Event             1
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description

Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

bortezomib: Given SC

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
78
(61 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  16.7%
White
5
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patient who began maintenance treatment with bortezomib after induction of remission
Arm/Group Title Treated Patients
Hide Arm/Group Description:

Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

bortezomib: Given SC

Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: days
107
(14 to 575)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description

Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

bortezomib: Given SC

All-Cause Mortality
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%)
Total   5/6 (83.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Gastrointestinal disorders   
Cholechystitis * [1]  1/6 (16.67%)  1
Nervous system disorders   
Altered Mental Status * [1]  1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Serious as required hospitalization, but not related to study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Nervous system disorders   
Peripheral neuropathy * [1]  1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Grade 2 peripheral neuropathy, a known adverse effect of study drug
Difficulty finding patients willing or available to come in to clinic for weekly injections for the duration of the study. Study was ultimately closed because of slow enrollment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Elihu Estey, MD
Organization: FHCRC
Phone: 206-288-7176
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01465386     History of Changes
Other Study ID Numbers: 2529.00
NCI-2011-03115 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 10, 2011
First Posted: November 4, 2011
Results First Submitted: February 17, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017