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CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00659425
First Posted: April 16, 2008
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
MedImmune LLC
Results First Submitted: February 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Intervention: Drug: CAT-8015 (Moxetumomab Pasudotox)

  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 57 participants were enrolled of which 55 participants received treatment.

Reporting Groups
  Description
5 Microgram Per Kilogram (mcg/kg) Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10 Microgram Per Kilogram (mcg/kg) Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
20 Microgram Per Kilogram (mcg/kg): Schema A Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
20 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
30 Microgram Per Kilogram (mcg/kg): Schema A Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
30 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
40 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
32 Microgram Per Kilogram (mcg/kg): Schema C Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
50 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
50 Microgram Per Kilogram (mcg/kg): Schema C Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.

Participant Flow:   Overall Study
    5 Microgram Per Kilogram (mcg/kg)   10 Microgram Per Kilogram (mcg/kg)   20 Microgram Per Kilogram (mcg/kg): Schema A   20 Microgram Per Kilogram (mcg/kg): Schema B   30 Microgram Per Kilogram (mcg/kg): Schema A   30 Microgram Per Kilogram (mcg/kg): Schema B   40 Microgram Per Kilogram (mcg/kg): Schema B   32 Microgram Per Kilogram (mcg/kg): Schema C   50 Microgram Per Kilogram (mcg/kg): Schema B   50 Microgram Per Kilogram (mcg/kg): Schema C
STARTED   1   1   1   4   4   5   8   11   6   14 
COMPLETED   0   0   0   0   0   1   0   0   0   1 
NOT COMPLETED   1   1   1   4   4   4   8   11   6   13 
Disease progression                1                0                0                1                0                2                4                3                5                3 
Death                0                0                0                1                0                0                1                0                0                0 
Adverse Event                0                0                0                0                0                1                0                3                1                4 
Investigator Discretion                0                0                0                0                0                1                0                3                0                0 
Other                0                1                1                2                4                0                3                2                0                6 



  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 includes all participants who received any treatment of study drug.

Reporting Groups
  Description
5 Microgram Per Kilogram (mcg/kg) Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10 Microgram Per Kilogram (mcg/kg) Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
20 Microgram Per Kilogram (mcg/kg): Schema A Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
20 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
30 Microgram Per Kilogram (mcg/kg): Schema A Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
30 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
40 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
32 Microgram Per Kilogram (mcg/kg): Schema C Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
50 Microgram Per Kilogram (mcg/kg): Schema B Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
50 Microgram Per Kilogram (mcg/kg): Schema C Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Total Total of all reporting groups

Baseline Measures
   5 Microgram Per Kilogram (mcg/kg)   10 Microgram Per Kilogram (mcg/kg)   20 Microgram Per Kilogram (mcg/kg): Schema A   20 Microgram Per Kilogram (mcg/kg): Schema B   30 Microgram Per Kilogram (mcg/kg): Schema A   30 Microgram Per Kilogram (mcg/kg): Schema B   40 Microgram Per Kilogram (mcg/kg): Schema B   32 Microgram Per Kilogram (mcg/kg): Schema C   50 Microgram Per Kilogram (mcg/kg): Schema B   50 Microgram Per Kilogram (mcg/kg): Schema C   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   1   4   4   5   8   11   6   14   55 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 17 [1]   8 [1]   17 [1]   12.8  (6.8)   9  (2.7)   14  (4.7)   8.6  (5.3)   13.8  (6.3)   12.8  (8.3)   14.3  (5.5)   12.7  (5.9) 
[1] Standard Deviation is not evaluable for single participant.
Sex: Female, Male 
[Units: Participants]
Count of Participants
                     
Female      1 100.0%      0   0.0%      0   0.0%      3  75.0%      0   0.0%      0   0.0%      3  37.5%      6  54.5%      2  33.3%      6  42.9%      21  38.2% 
Male      0   0.0%      1 100.0%      1 100.0%      1  25.0%      4 100.0%      5 100.0%      5  62.5%      5  45.5%      4  66.7%      8  57.1%      34  61.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dose Limiting Toxicities (DLTs)   [ Time Frame: Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days) ]

2.  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 ]

3.  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 ]

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 up to 30 days after the last dose of study drug ]

5.  Primary:   Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants   [ Time Frame: From start of study drug administration up to 30 days after the last dose of study drug ]

6.  Primary:   Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment) ]

7.  Primary:   Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) ]

8.  Primary:   Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment) ]

9.  Primary:   Best Overall Tumor Response   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) ]

10.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) ]

11.  Primary:   Percentage of Participants With Relapse of Disease   [ Time Frame: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) ]

12.  Primary:   Time to Disease Response   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) ]

13.  Primary:   Duration of Response (DR)   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment ]

14.  Primary:   Time to Disease Progression (TDP)   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment ]

15.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) ]

16.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) ]

17.  Primary:   Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox   [ Time Frame: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 ]

18.  Primary:   Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox   [ Time Frame: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 ]

19.  Primary:   Systemic Clearance (CL) for Moxetumomab Pasudotox   [ Time Frame: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 ]

20.  Primary:   Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox   [ Time Frame: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 ]

21.  Secondary:   Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody   [ Time Frame: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) ]

22.  Secondary:   CD22 Expression Cells in Peripheral Blood by Best Response   [ Time Frame: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) ]

23.  Secondary:   Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)   [ Time Frame: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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 Lanasa, MD Associate Director, Clinical Development, Oncology
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: information.center@AstraZeneca.com


Publications of Results:
Wayne AS, Shah NN, Bhojwani D, Silverman LB, Whitlock JA, Stetler-Stevenson M, et al. Pediatric phase 1 trial of moxetumomab pasudotox: activity in chemotherapy refractory acute lymphoblastic leukemia (ALL) . http://cancerres.aacrjournals.org/content/74/19_Supplement/CT230.short


Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00659425     History of Changes
Other Study ID Numbers: CAT-8015-1004
First Submitted: April 10, 2008
First Posted: April 16, 2008
Results First Submitted: February 24, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017