Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) (BLAST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT01207388
First received: September 21, 2010
Last updated: January 28, 2015
Last verified: January 2014
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: B-cell Acute Lymphoblastic Leukemia
Intervention: Drug: Blinatumomab

  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 open to adults with a diagnosis of minimal residual disease (MRD; ≥ 10^-3 leukemic cells) -positive B-precursor acute lymphoblastic leukemia (ALL) who were in complete hematologic remission.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Results are reported for the primary analysis (conducted when all participants had been evaluated for the primary efficacy endpoint; data cutoff date of 21 February 2014). The core study was defined as completing 4 cycles for participants not proceeding to HSCT and completion of at least Day 29 of Cycle 1 for those proceeding to HSCT.

Reporting Groups
  Description
Blinatumomab

Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.

Participants suitable for allogeneic hematopoietic stem cell transplant (HSCT) after treatment with at least 1 cycle of blinatumomab may have undergone allogeneic HSCT instead of receiving further cycles with blinatumomab.


Participant Flow:   Overall Study
    Blinatumomab  
STARTED     116  
COMPLETED     74 [1]
NOT COMPLETED     42  
Adverse Event                 20  
Disease Relapse                 11  
Physician Decision                 1  
Treatment Ongoing                 10  
[1] Completed the core study



  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.
No text entered.

Reporting Groups
  Description
Blinatumomab Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.

Baseline Measures
    Blinatumomab  
Number of Participants  
[units: participants]
  116  
Age  
[units: years]
Mean (Standard Deviation)
  44.6  (16.4)  
Age, Customized  
[units: participants]
 
≥ 18 and <35 years     36  
≥ 35 and < 55 years     41  
≥ 55 and < 65 years     24  
≥ 65 years     15  
Gender  
[units: participants]
 
Female     48  
Male     68  
Race/Ethnicity, Customized [1]
[units: participants]
 
White     102  
Asian     1  
Mixed     1  
Unknown     12  
Philadelphia Chromosome Disease Status  
[units: participants]
 
Positive     5  
Negative     111  
Confirmed t(4;11) Translocation / MLL-AF4+ ALL [2]
[units: participants]
  5  
MRD Level at Baseline by Central Laboratory [3]
[units: participants]
 
≥ 10^-1 and < 1     9  
≥ 10^-2 and < 10^-1     45  
≥ 10^-3 and < 10^-2     52  
< 10^-3     3  
Below Lower Limit of Quantification     5  
Unknown     2  
White Blood Cells at First Diagnosis  
[units: participants]
 
≤ 30,000/mL     78  
> 30,000/mL     18  
Unknown     20  
[1] Race was not permitted to be collected in France.
[2] t(4;11)(q21;q23) translocation, resulting in the fusion of the mixed lineage leukemia (MLL) gene on chromosome 11 and the AF4 gene on chromosome 4
[3] Measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory; Lower limit of quantification = 10^-4 leukemic cells.



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle   [ Time Frame: During the first cycle (6 weeks) ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Adverse events are reported until the data cut-off date of 21 February 2014; the median treatment duration was 52 days. ]

3.  Secondary:   Hematological Relapse-free Survival Rate   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No

5.  Secondary:   100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant   [ Time Frame: 100 days after HSCT ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No

6.  Secondary:   Time to Hematological Relapse   [ Time Frame: Up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No

7.  Secondary:   Duration of Complete MRD Response   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No

8.  Secondary:   MRD Level   [ Time Frame: Up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No

9.  Secondary:   Quality of Life   [ Time Frame: Up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No

10.  Secondary:   Resource Utilization   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   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 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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier: NCT01207388     History of Changes
Other Study ID Numbers: MT103-203
Study First Received: September 21, 2010
Results First Received: January 28, 2015
Last Updated: January 28, 2015
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)