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A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia

This study has been terminated.
(The study is terminated early due to unavailability of investigational product.)
Sponsor:
Collaborator:
Cambridge Antibody Technology
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00587457
First received: December 21, 2007
Last updated: February 27, 2017
Last verified: February 2017
Results First Received: February 27, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Leukemia, Lymphoma, Chronic Lymphocytic
Leukemia, Prolymphocytic Leukemia, Small
Lymphocytic Lymphoma, Moxetumomab Pasudotox
Interventions: Drug: CAT-8015 5 mcg/kg
Drug: CAT-8015 10 mcg/kg
Drug: CAT-8015 20 mcg/kg

  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
A total of 11 participants were enrolled, of which all participants discontinued from the treatment.

Reporting Groups
  Description
CAT-8015 5 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
CAT-8015 10 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
CAT-8015 20 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Participant Flow:   Overall Study
    CAT-8015 5 Microgram Per Kilogram (mcg/kg)   CAT-8015 10 Microgram Per Kilogram (mcg/kg)   CAT-8015 20 Microgram Per Kilogram (mcg/kg)
STARTED   3   3   5 
COMPLETED   0   0   0 
NOT COMPLETED   3   3   5 
Adverse Event                1                2                1 
Disease progression                2                0                2 
Initiation of alternative therapy                0                1                0 
Undefined                0                0                1 
Development of neutralizing Abs                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.
Safety population included all participants who received any treatment of moxetumomab pasudotox.

Reporting Groups
  Description
CAT-8015 5 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
CAT-8015 10 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
CAT-8015 20 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
Total Total of all reporting groups

Baseline Measures
   CAT-8015 5 Microgram Per Kilogram (mcg/kg)   CAT-8015 10 Microgram Per Kilogram (mcg/kg)   CAT-8015 20 Microgram Per Kilogram (mcg/kg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   5   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.7  (2.3)   62.0  (4.4)   61.6  (7.5)   60.9  (5.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  33.3%      1  33.3%      1  20.0%      3  27.3% 
Male      2  66.7%      2  66.7%      4  80.0%      8  72.7% 


  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)   [ Time Frame: From start of study drug administration until 30 days after the last dose of study drug ]

2.  Primary:   Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: From start of study drug administration until 30 days after the last dose of study drug ]

3.  Primary:   Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)   [ Time Frame: From start of study drug administration until 30 days after the last dose of study drug ]

4.  Primary:   Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: From start of study drug administration until 30 days after the last dose of study drug ]

5.  Primary:   Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)   [ Time Frame: Up to 2 years of post-treatment follow-up ]

6.  Primary:   Best Overall Objective Tumor Response   [ Time Frame: Up to 2 years of post-treatment follow-up ]

7.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox   [ Time Frame: Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3 ]

8.  Primary:   Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox   [ Time Frame: Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3 ]

9.  Secondary:   Number of Participants With Positive Neutralizing Antibodies   [ Time Frame: Up to end of treatment (4-6 weeks after the last dose) ]

10.  Secondary:   Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) Expression   [ Time Frame: End of treatment (4-6 weeks after the last dose) ]


  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
The study was terminated early due to unavailability of investigational product.


  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: Mark C Lanasa
Organization: MedImmune, LLC.
phone: 301-398-0000
e-mail: clinicaltrialenquiries@medimmune.com



Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00587457     History of Changes
Other Study ID Numbers: CAT-8015-1002
Study First Received: December 21, 2007
Results First Received: February 27, 2017
Last Updated: February 27, 2017