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Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pamela S Becker, University of Washington
ClinicalTrials.gov Identifier:
NCT01872819
First received: June 4, 2013
Last updated: March 4, 2017
Last verified: March 2017
Results First Received: March 4, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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)
Chronic Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts
Interventions: Other: antitumor drug screening assay
Drug: chemotherapy
Biological: biological therapy

  Participant Flow
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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
Treatment (Chemotherapy, Biological Therapy)

Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.

antitumor drug screening assay: Undergo high throughput drug sensitivity assay

chemotherapy: Patients receive 1 of 160 possible interventions

biological therapy: Patients receive 1 of 160 possible interventions


Participant Flow:   Overall Study
    Treatment (Chemotherapy, Biological Therapy)
STARTED   16 
COMPLETED   14 
NOT COMPLETED   2 
Physician Decision                1 
Withdrawal by Subject                1 



  Baseline Characteristics
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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.
relapsed, refractory AML patients

Reporting Groups
  Description
Treatment (Chemotherapy, Biological Therapy)

Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.

antitumor drug screening assay: Undergo high throughput drug sensitivity assay

chemotherapy: Patients receive 1 of 160 possible interventions

biological therapy: Patients receive 1 of 160 possible interventions


Baseline Measures
   Treatment (Chemotherapy, Biological Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   6 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  37.5% 
Male      10  62.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      16 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2  12.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      14  87.5% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures

1.  Primary:   Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML   [ Time Frame: Up to 21 days ]

2.  Secondary:   Change in the Rate of Complete Response, Defined by Criteria of Cheson et al.   [ Time Frame: Baseline up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Dr. Pamela Becker
Organization: University of Washington
phone: 206-288-7273
e-mail: pbecker@u.washington.edu



Responsible Party: Pamela S Becker, University of Washington
ClinicalTrials.gov Identifier: NCT01872819     History of Changes
Other Study ID Numbers: 8003
NCI-2013-01070 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8003 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: June 4, 2013
Results First Received: March 4, 2017
Last Updated: March 4, 2017