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Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00807495
Recruitment Status : Completed
First Posted : December 12, 2008
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Burkitt's Lymphoma
T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma
Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component
Intervention: Drug: Alisertib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 12 investigative sites in the United States from 10 February 2009 to last participant off study 13 February 2013, with a data cut-off on 04 January 2011 to report the primary endpoint.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of Aggressive Non-Hodgkin’s Lymphoma received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are categorized as disease sub-types: Diffuse Large B-cell lymphoma (DLBL), Mantle Cell lymphoma (MCL), Transformed Follicular lymphoma (TFL), Burkitts lymphoma (BL) and Aggressive T-Cell lymphoma (ATL).

Reporting Groups
  Description
Alisertib 50 mg BID Starting Dose (DLBL) Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (MCL) Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (TFL) Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (BL) Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (ATL) Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).

Participant Flow:   Overall Study
    Alisertib 50 mg BID Starting Dose (DLBL)   Alisertib 50 mg BID Starting Dose (MCL)   Alisertib 50 mg BID Starting Dose (TFL)   Alisertib 50 mg BID Starting Dose (BL)   Alisertib 50 mg BID Starting Dose (ATL)
STARTED   22   13   5   1   7 [1] 
COMPLETED   14 [2]   7   1   0   2 
NOT COMPLETED   8   6   4   1   5 
Adverse Event                6                3                1                1                2 
Withdrawal by Patient                2                0                1                0                0 
Reason Not Specified                0                3                2                0                3 
[1] An ATL participant had late on-study biopsy and was in DLBL, reducing ATL participants from 8 to 7.
[2] Completed = participants who completed the study treatment to PD or symptomatic deterioration.



  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.
Safety population was defined as all participants who received any amount of alisertib.

Reporting Groups
  Description
Alisertib 50 mg BID Starting Dose (DLBL) Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (MCL) Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (TFL) Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (BL) Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Alisertib 50 mg BID Starting Dose (ATL) Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Total Total of all reporting groups

Baseline Measures
   Alisertib 50 mg BID Starting Dose (DLBL)   Alisertib 50 mg BID Starting Dose (MCL)   Alisertib 50 mg BID Starting Dose (TFL)   Alisertib 50 mg BID Starting Dose (BL)   Alisertib 50 mg BID Starting Dose (ATL)   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   13   5   1   7   48 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 66.8  (11.11)   67.2  (6.71)   65.2  (9.96)   76.0 [1]   54.4  (16.90)   65.1  (11.56) 
[1] Standard deviation was not estimable as only 1 participant was analyzed in this arm group.
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      9  40.9%      1   7.7%      3  60.0%      0   0.0%      0   0.0%      13  27.1% 
Male      13  59.1%      12  92.3%      2  40.0%      1 100.0%      7 100.0%      35  72.9% 
Race/Ethnicity, Customized 
[Units: Participants]
           
White   21   13   5   1   7   47 
Other   1   0   0   0   0   1 
Race/Ethnicity, Customized 
[Units: Participants]
           
Hispanic or Latino   1   0   1   0   1   3 
Not Hispanic or Latino   21   13   4   1   6   45 
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 88.85  (27.022)   96.18  (25.139)   89.06  (29.724)   72.58 [1]   84.45  (14.494)   89.88  (24.737) 
[1] Standard deviation was not estimable as only 1 participant was analyzed in this arm group.


  Outcome Measures

1.  Primary:   Best Overall Response Rate Based on Investigator’s Assessment (Applying the IWG 2007 Response Criteria)   [ Time Frame: Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years) ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) ]

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) ]

5.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events   [ Time Frame: First dose of study drug to 30 days after last dose (Up to 25 months) ]

6.  Secondary:   Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events   [ Time Frame: First dose of study drug to 30 days after last dose (Up to 25 months) ]

7.  Secondary:   Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events   [ Time Frame: First dose of study drug to 30 days after last dose (Up to 25 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com


Publications of Results:

Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00807495     History of Changes
Other Study ID Numbers: C14004
U1111-1187-1268 ( Registry Identifier: WHO )
First Submitted: December 11, 2008
First Posted: December 12, 2008
Results First Submitted: January 4, 2018
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018