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Ixazomib (MLN9708) in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02030405
Recruitment Status : Terminated (Regulatory)
First Posted : January 8, 2014
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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 Del(5q)
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)
Recurrent Adult Acute Myeloid Leukemia
Intervention Drug: ixazomib
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ixazomib (MLN9708)
Hide Arm/Group Description Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 4
Completed 2
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             1
Arm/Group Title Ixazomib (MLN9708)
Hide Arm/Group Description Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  25.0%
>=65 years
3
  75.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 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
  25.0%
White
2
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  25.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description

Overall response rate after 3 cycles of treatment (9 weeks) was assessed as complete remission (CR); CR with incomplete recovery (CRi); and partial remission (PR) with MLN9708, in patients with NPM1-mutated AML by LeukemiaNet1 guidelines:

CR is defined as either a full CR, or a CR with incomplete recovery. Although achievement of CR has unique clinical significance for improved overall survival and relapsed free survival compared to achievement of CR with incomplete platelet recovery, the latter is still a clinically meaningful response, as it is independently superior to resistant disease. Partial remission (PR) is defined as meeting all hematologic criteria for CR with an allowance for 5% to 25% bone marrow blasts or decrease of pretreatment bone marrow blast percentage by at least 50%. Stable disease is defined as a change in bone marrow aspirate blast count within 10% of baseline. Relapsed disease is defined as reappearance of blasts in the blood or bone marrow blasts

Time Frame 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ixazomib (MLN9708)
Hide Arm/Group Description:
Patients receive ixazomib orally on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Remission (CR)
0
   0.0%
Complete Remission with incomplete recovery (CRi)
0
   0.0%
Partial Remission (PR)
0
   0.0%
Stable Disease (SD)
0
   0.0%
Relapsed Disease (RD)
0
   0.0%
Progressive Disease (PD)
2
 100.0%
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) from time of study entry to the earlier of death from any cause or end of follow up at 1 year
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ixazomib (MLN9708)
Hide Arm/Group Description:
Ixazomib was administered PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ixazomib (MLN9708)
Hide Arm/Group Description Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Ixazomib (MLN9708)
Affected / at Risk (%)
Total   4/4 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ixazomib (MLN9708)
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
AML Disease progression * 1  2/4 (50.00%)  2
pancytopenia * 1  1/4 (25.00%)  1
Cardiac disorders   
Cardiopulmonary Arrest * 1  1/4 (25.00%)  1
Gastrointestinal disorders   
Diarrhea * 1  2/4 (50.00%)  2
Nausea * 1  1/4 (25.00%)  1
General disorders   
Dehydration * 1  1/4 (25.00%)  1
Infections and infestations   
Febrile Neutropenia * 1  1/4 (25.00%)  1
Renal and urinary disorders   
acute kidney injury * 1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Distress Syndrome * 1  1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ixazomib (MLN9708)
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Gastrointestinal disorders   
Vomiting * 1  1/4 (25.00%)  1
Diarrhea * 1  2/4 (50.00%)  2
Nausea * 1  2/4 (50.00%)  2
Renal and urinary disorders   
Rectal Pain * 1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Pulmonary Edema * 1  1/4 (25.00%)  1
Dysphagia * 1  1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
Skin Rash * 1 [1]  2/4 (50.00%)  2
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
including: Maculo-papular rash
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: Bruno Carneiro de Medeiros, MD
Organization: Stanford University Medical Center
Phone: 650-498-6000
Responsible Party: Bruno C. Medeiros, Stanford University
ClinicalTrials.gov Identifier: NCT02030405     History of Changes
Other Study ID Numbers: IRB-28771
NCI-2013-02231 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA124435 ( U.S. NIH Grant/Contract )
HEMAML0028 ( Other Identifier: OnCore Number )
First Submitted: November 25, 2013
First Posted: January 8, 2014
Results First Submitted: January 20, 2017
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017