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Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy (PILLAR2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00790036
First received: November 11, 2008
Last updated: June 14, 2017
Last verified: June 2017
Results First Received: June 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Prevention
Condition: Diffuse Large B-cell Lymphoma
Interventions: Drug: Everolimus
Drug: Everolimus Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Considering a recruitment period of 53 months and a final primary analysis performed after an anticipated duration of 69 months after study start, 727 patients had to be included. Actual enrolled: 742.

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
RAD001 (Everolimus)1 RAD001 10 mg (two 5 mg tablets), daily for 12 months
Placebo Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months

Participant Flow:   Overall Study
    RAD001 (Everolimus)1   Placebo
STARTED   372   370 
Untreated Participants   4 [1]   6 [2] 
COMPLETED   177 [3]   249 [3] 
NOT COMPLETED   195   121 
Abnormal lab values                3                2 
Administrative problems                5                9 
Adverse Event                113                44 
Death                1                0 
Disease progression                24                48 
Lost to Follow-up                1                2 
Protocol Violation                10                2 
Withdrawal by Subject                18                7 
Subject/guardian decision                20                7 
[1] not treated due to administrative problems, protocol deviation, and subject withdrawal of consent.
[2] not treated due to administrative problems and subject withdrawal of consent.
[3] completed = treatment duration completed as per protocol



  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.
Full Analysis Set (FAS) includes all randomized patients.

Reporting Groups
  Description
RAD001 (Everolimus)1 RAD001 10 mg (two 5 mg tablets), daily for 12 months
Placebo Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
Total Total of all reporting groups

Baseline Measures
   RAD001 (Everolimus)1   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 372   370   742 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.6  (13.72)   60.9  (13.61)   60.7  (13.66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      204  54.8%      166  44.9%      370  49.9% 
Male      168  45.2%      204  55.1%      372  50.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease-free Survival (DFS)   [ Time Frame: From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From date of randomization to date of death due to any cause up to around 7 years ]

3.  Secondary:   Lymphoma-specific Survival (LSS)   [ Time Frame: From randomization to death documented as a result of lymphoma up to 7 years ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00790036     History of Changes
Other Study ID Numbers: CRAD001N2301
2008-000498-40 ( EudraCT Number )
Study First Received: November 11, 2008
Results First Received: June 14, 2017
Last Updated: June 14, 2017