Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT01013961
First received: November 13, 2009
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Interventions: Biological: alemtuzumab
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
This study was activated on October 8, 2010 and closed on October 31, 2013 with a total of 31 patients accrued.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Peripheral blood (preferred) or bone marrow must be submitted at pre-registration for FISH risk analysis to determine stratification factor before randomization.

Reporting Groups
  Description
Arm A (Standard Dose)

Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.

Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week.

Arm B (Low Dose)

Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.

Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week.


Participant Flow:   Overall Study
    Arm A (Standard Dose)     Arm B (Low Dose)  
STARTED     16     15  
COMPLETED     13     12  
NOT COMPLETED     3     3  
Adverse Event                 2                 2  
Withdrawal by Subject                 1                 0  
Physician Decision                 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 randomized patients

Reporting Groups
  Description
Arm A (Standard Dose)

Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.

Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week.

Arm B (Low Dose)

Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.

Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week.

Total Total of all reporting groups

Baseline Measures
    Arm A (Standard Dose)     Arm B (Low Dose)     Total  
Number of Participants  
[units: participants]
  16     15     31  
Age  
[units: years]
Median (Full Range)
  77  
  (67 to 92)  
  76  
  (72 to 83)  
  76  
  (67 to 92)  
Gender  
[units: participants]
     
Female     6     7     13  
Male     10     8     18  



  Outcome Measures
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1.  Primary:   Proportion of Patients With Complete Response (CR)   [ Time Frame: Assessed after 2 cycles of treatment and 2 months after completion of therapy ]

2.  Primary:   Proportion of Patients With Overall Response (OR)   [ Time Frame: Assessed after 2 cycles of treatment and 2 months after completion of therapy ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years ]

5.  Secondary:   Time to Response   [ Time Frame: Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years ]

6.  Secondary:   Duration of Response   [ Time Frame: Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 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
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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: Study Statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012



Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT01013961     History of Changes
Other Study ID Numbers: E1908
E1908 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180794 ( US NIH Grant/Contract Award Number )
Study First Received: November 13, 2009
Results First Received: December 22, 2015
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration