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Trial record 63 of 493 for:    LENALIDOMIDE AND every 28 days

Lenalidomide in HTLV-1 Adult T-Cell Leukemia

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ClinicalTrials.gov Identifier: NCT01274533
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : April 22, 2016
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult T Cell Leukemia/Lymphoma
Intervention Drug: Lenalidomide
Enrollment 4
Recruitment Details The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.

Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle

Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Non-compliance             1
Disease progression             2
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.

Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18 years and older Number Analyzed 4 participants
4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Response Rate (CR + Cru + PR)
Hide Description Peripheral blood, CT or MRI
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:

Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.

Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Safety of Lenalidomide Monotherapy
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:

Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.

Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the AE data.
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.

Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle

All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide
Affected / at Risk (%)
Total   0/0 
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
Layout table for Results Point of Contact information
Name/Title: CU PRS Administrator
Organization: Columbia University
Phone: 212-342-1643
EMail: crchelp@columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01274533     History of Changes
Other Study ID Numbers: AAAE5097
First Submitted: January 10, 2011
First Posted: January 11, 2011
Results First Submitted: March 23, 2016
Results First Posted: April 22, 2016
Last Update Posted: May 23, 2016