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Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma

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: NCT02272686
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 23, 2014
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Intervention Drug: Ibrutinib
Enrollment 1
Recruitment Details Recruitment Period 6/3/2016 to 2/21/2017.
Pre-assignment Details Ibrutinib maintenance will not be started if patient relapses post transplant
Arm/Group Title Ibrutinib Maintenance
Hide Arm/Group Description Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Ibrutinib Maintenance
Hide Arm/Group Description Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
1
 100.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Disease Free Survival (DFS)
Hide Description Participants will be assessed for disease status and survival.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibrutinib Maintenance
Hide Arm/Group Description:
Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Participants will be assessed at 3 year time point for survival.
Time Frame Three Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibrutinib Maintenance
Hide Arm/Group Description:
Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame through study completion, an average of 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibrutinib Maintenance
Hide Arm/Group Description Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
All-Cause Mortality
Ibrutinib Maintenance
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ibrutinib Maintenance
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ibrutinib Maintenance
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Issa F. Khouri, MD, Professor, Stem Cell Transplantation
Organization: UT MD Anderson Cancer Center
Phone: 713-745-0049
EMail: ikhouri@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02272686     History of Changes
Other Study ID Numbers: 2014-0096
NCI-2015-00843 ( Registry Identifier: NCI CTRP )
First Submitted: October 21, 2014
First Posted: October 23, 2014
Results First Submitted: October 2, 2018
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018