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Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01369849
First received: June 8, 2011
Last updated: May 20, 2016
Last verified: May 2016
Results First Received: May 20, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Interventions: Drug: Akt Inhibitor MK2206
Drug: Bendamustine Hydrochloride
Other: Laboratory Biomarker Analysis
Biological: Rituximab

  Participant Flow
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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: Dose Level 1

Patients receive:

Cycle 1:

  1. Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
  2. Rituximab IV 375 mg/m^2 on day 8.
  3. Bendamustine IV 70 mg/m^2 on day 8 and 9.

Cycles 2-6:

  1. Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
  2. Rituximab IV 500 mg/m^2 on day 1.
  3. Bendamustine IV 70 mg/m^2 on day 1 and 2.
Phase I: Dose Level 2

Patients receive:

Cycle 1:

  1. Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
  2. Rituximab IV 375 mg/m^2 on day 8.
  3. Bendamustine IV 70 mg/m^2 on day 8 and 9.

Cycles 2-6:

  1. Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
  2. Rituximab IV 500 mg/m^2 on day 1.
  3. Bendamustine IV 70 mg/m^2 on day 1 and 2.
Phase II

Patients receive:

Cycle 1:

  1. Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
  2. Rituximab IV 375 mg/m^2 on day 8.
  3. Bendamustine IV 70 mg/m^2 on day 8 and 9.

Cycles 2-6:

  1. Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
  2. Rituximab IV 500 mg/m^2 on day 1.
  3. Bendamustine IV 70 mg/m^2 on day 1 and 2.

Participant Flow:   Overall Study
    Phase I: Dose Level 1     Phase I: Dose Level 2     Phase II  
STARTED     6     4     5  
COMPLETED     6     4     4  
NOT COMPLETED     0     0     1  
Ineligible prior to treatment                 0                 0                 1  



  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.
All patients that began protocol treatment were included in the baseline analysis.

Reporting Groups
  Description
Phase I: Dose Level 1

Patients receive:

Cycle 1:

  1. Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
  2. Rituximab IV 375 mg/m^2 on day 8.
  3. Bendamustine IV 70 mg/m^2 on day 8 and 9.

Cycles 2-6:

  1. Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
  2. Rituximab IV 500 mg/m^2 on day 1.
  3. Bendamustine IV 70 mg/m^2 on day 1 and 2.
Phase I: Dose Level 2

Patients receive:

Cycle 1:

  1. Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
  2. Rituximab IV 375 mg/m^2 on day 8.
  3. Bendamustine IV 70 mg/m^2 on day 8 and 9.

Cycles 2-6:

  1. Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
  2. Rituximab IV 500 mg/m^2 on day 1.
  3. Bendamustine IV 70 mg/m^2 on day 1 and 2.
Phase II

Patients receive:

Cycle 1:

  1. Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)
  2. Rituximab IV 375 mg/m^2 on day 8.
  3. Bendamustine IV 70 mg/m^2 on day 8 and 9.

Cycles 2-6:

  1. Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)
  2. Rituximab IV 500 mg/m^2 on day 1.
  3. Bendamustine IV 70 mg/m^2 on day 1 and 2.
Total Total of all reporting groups

Baseline Measures
    Phase I: Dose Level 1     Phase I: Dose Level 2     Phase II     Total  
Number of Participants  
[units: participants]
  6     4     4     14  
Age  
[units: years]
Median (Full Range)
  67.5  
  (44 to 74)  
  66.5  
  (61 to 71)  
  65  
  (54 to 75)  
  67  
  (44 to 75)  
Gender  
[units: participants]
       
Female     1     1     0     2  
Male     5     3     4     12  
Region of Enrollment  
[units: participants]
       
United States     6     4     4     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose of Akt Inhibitor MK2206 (Phase I)   [ Time Frame: Up to 35 days ]

2.  Primary:   Proportion of Complete Response Defined to be a CR or CRi Noted as the Objective Status (Phase II)   [ Time Frame: From registration to response, up to 84 days ]

3.  Secondary:   Biomarker Analysis (IgVH Gene Mutation, CD38, CD49d, ZAP-70 and FISH Status)   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Duration of Response   [ Time Frame: The date at which the patient’s objective status is first noted to be a CR, CRi, CCR, nPR, or PR to the earliest date progression is documented, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Minimal-residual Disease   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Overall Response Rate, Estimated by the Total Number of Complete or Partial Responses (CR, CRi, CCR, nPR, or PR) Divided by the Total Number of Evaluate Patients   [ Time Frame: 3 months post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Treatment-free Survival   [ Time Frame: Time from registration to the date of initiation of subsequent therapy or death, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wei Ding, MBBS, PhD
Organization: Mayo Clinic
e-mail: ding.wei@mayo.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01369849     History of Changes
Other Study ID Numbers: NCI-2011-02675
NCI-2011-02675 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000701372
NCCTG-N1087
N1087 ( Other Identifier: Alliance for Clinical Trials in Oncology )
N1087 ( Other Identifier: CTEP )
U10CA180821 ( US NIH Grant/Contract Award Number )
U10CA025224 ( US NIH Grant/Contract Award Number )
Study First Received: June 8, 2011
Results First Received: May 20, 2016
Last Updated: May 20, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government