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Rituximab, Lenalidomide, and Bortezomib in Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Celgene
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00633594
First received: March 4, 2008
Last updated: December 6, 2016
Last verified: December 2016
Results First Received: August 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mantle Cell Lymphoma
Interventions: Drug: Rituximab
Drug: Bortezomib
Drug: Lenalidomide

  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
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
Phase I - Lenalidomide 15mg PO QD Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14.
Phase I - Lenalidomide 10mg PO QD Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
Phase II - Lenalidomide 10mg PO QD Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.

Participant Flow:   Overall Study
    Phase I - Lenalidomide 15mg PO QD   Phase I - Lenalidomide 10mg PO QD   Phase II - Lenalidomide 10mg PO QD
STARTED   5   8   26 
COMPLETED   5   3   16 
NOT COMPLETED   0   5   10 
Adverse Event                0                4                7 
Death                0                1                2 
Disease Progression                0                0                1 



  Baseline Characteristics
  Hide 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.
Based on efficacy evaluable population, all participants that received any study therapy. Participants were stratified based on phase of study (Phase I vs Phase II) and previous treatment status prior to study start (Previously Untreated vs Previously Treated (relapsed or refractory))

Reporting Groups
  Description
Phase I - Lenalidomide 15mg PO QD Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. .
Phase I - Lenalidomide 10mg PO QD Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
Phase II - Lenalidomide 10mg PO QD Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
Total Total of all reporting groups

Baseline Measures
   Phase I - Lenalidomide 15mg PO QD   Phase I - Lenalidomide 10mg PO QD   Phase II - Lenalidomide 10mg PO QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   8   26   39 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3  60.0%      2  25.0%      7  26.9%      12  30.8% 
>=65 years      2  40.0%      6  75.0%      19  73.1%      27  69.2% 
Age 
[Units: Years]
Median (Full Range)
 60 
 (52 to 70) 
 69 
 (60 to 80) 
 69 
 (55 to 88) 
 69 
 (52 to 88) 
Age, Customized 
[Units: Participants]
Count of Participants
       
Previously Treated : <= 18 years   0   0   0   0 
Previously Treated : Between 18 and 65 years   3   0   0   3 
Previously Treated : >= 65 years   1   1   5   7 
Previously Untreated : <= 18 years   0   0   0   0 
Previously Untreated : Between 18 and 65 years   0   2   7   9 
Previously Untreated : >= 65 years   1   5   14   20 
Gender, Customized [1] 
[Units: Participants]
Count of Participants
       
Previously Treated : Female   1   1   2   4 
Previously Treated : Male   3   0   3   6 
Previously Untreated : Female   0   1   5   6 
Previously Untreated : Male   1   6   16   23 
[1] Gender based on participants' previous treatment prior to initiating study treatment (previously treated and previously untreated)
Gender 
[Units: Participants]
Count of Participants
       
Female      1  20.0%      2  25.0%      7  26.9%      10  25.6% 
Male      4  80.0%      6  75.0%      19  73.1%      29  74.4% 
Region of Enrollment 
[Units: Participants]
       
United States   5   8   26   39 
Previous Treatment for Mantle Cell Lymphoma (MCL) [1] 
[Units: Participants]
       
Previously Untreated   1   7   21   29 
Previously Treated   4   1   5   10 
[1] Includes participants with relapsed or refractory MCL who have received one previous treatment prior to starting study treatment, and those with previously untreated MCL prior to starting study treatment.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants   [ Time Frame: Collected from day of first dose to the end of the first treatment cycle, up to 21 days ]

2.  Primary:   Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II   [ Time Frame: Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment ]

3.  Secondary:   Overall Response Rate (ORR) of Phase I and Phase II Participants   [ Time Frame: Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months ]

4.  Secondary:   Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants   [ Time Frame: Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months ]

5.  Secondary:   Time to Best Response of Phase I and Phase II Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years ]

6.  Secondary:   Time to Best Response of Previously Treated and Previously Untreated Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years ]

7.  Secondary:   Duration of Response (DoR) of Phase I and Phase II Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression ]

8.  Secondary:   Duration of Response (DoR) of Previously Treated and Previously Untreated Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression ]

9.  Secondary:   Progression Free Survival (PFS) of Phase I and Phase II Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression ]

10.  Secondary:   Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression ]

11.  Secondary:   Overall Survival of Phase I and Phase II Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression ]

12.  Secondary:   Overall Survival of Previously Treated and Previously Untreated Participants   [ Time Frame: Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression ]


  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 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: Ian Flinn, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


Publications:


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00633594     History of Changes
Other Study ID Numbers: SCRI LYM 58
Study First Received: March 4, 2008
Results First Received: August 19, 2016
Last Updated: December 6, 2016