ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 187 for:    "Acute erythroleukemia" "Acute erythroid leukemia"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ixazomib (MLN9708) 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.

Participant Flow:   Overall Study
    Ixazomib (MLN9708)
STARTED   4 
COMPLETED   2 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Lost to Follow-up                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ixazomib (MLN9708) 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.

Baseline Measures
   Ixazomib (MLN9708) 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  25.0% 
>=65 years      3  75.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      4 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: 9 weeks ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: bruno.medeiros@stanford.edu



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