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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: March 30, 2017
Last verified: March 2017
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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 key secondary analysis (conducted when all participants had completed 18 months of follow-up; data cutoff date of 05 August 2015). 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   83 [1] 
NOT COMPLETED   33 
Adverse Event                20 
Disease Relapse                10 
Physician Decision                2 
Other                1 
[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.
Full analysis set (all participants who received any infusion of blinatumomab)

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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      48  41.4% 
Male      68  58.6% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
White   102 
Asian   1 
Mixed   1 
Unknown   12 
[1] Race was not permitted to be collected in France.
Philadelphia Chromosome Disease Status 
[Units: Participants]
 
Positive   5 
Negative   111 
Confirmed t(4;11) Translocation / MLL-AF4+ ALL [1] 
[Units: Participants]
 5 
[1] 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
MRD Level at Baseline by Central Laboratory [1] 
[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 
[1] Measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory; Lower limit of quantification was at least 10^-4 leukemic cells.
White Blood Cells at First Diagnosis 
[Units: Participants]
 
≤ 30,000/mL   78 
> 30,000/mL   18 
Unknown   20 


  Outcome Measures
  Show All Outcome Measures

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:   Hematological Relapse-free Survival (RFS)   [ Time Frame: 18 months ]

3.  Secondary:   Overall Survival   [ Time Frame: Until the data cut-off date of 05 August 2015; median time on study was 18.3 months. ]

4.  Secondary:   100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant   [ Time Frame: 100 days after HSCT, as of the data cut-off date of 05 August 2015 ]

5.  Secondary:   Time to Hematological Relapse   [ Time Frame: Until the data cut-off date of 05 August 2015; median time on study was 18.3 months. ]

6.  Secondary:   Duration of Complete MRD Response   [ Time Frame: Until the data cut-off date of 05 August 2015; median time on study was 18.3 months. ]

7.  Secondary:   Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders   [ Time Frame: Baseline and end of cycle 1 (6 weeks) ]

8.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: From the first dose of blinatumomab until 30 days after last dose. Adverse events are reported up to the data cut-off date of 05 August 2015; the median treatment duration was 55 days. ]

9.  Secondary:   Change From Baseline in EORTC-QLQ-C30 Scales   [ Time Frame: Subjects are assessed at Screening Visit (Baseline), at day 29 of each treatment cycle, at Day 30 Safety Follow-Up Visit and during mandated Efficacy Follow-Up Visits occurring at month 3, 6, 9, 12, 18 and 24 after treatment start. ]

10.  Secondary:   Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales   [ Time Frame: Subjects are assessed at Screening Visit (Baseline), at day 29 of each treatment cycle, at Day 30 Safety Follow-Up Visit and during mandated Efficacy Follow-Up Visits occurring at month 3, 6, 9, 12, 18 and 24 after treatment start. ]

11.  Secondary:   Resource Utilization   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   01/2020  


  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



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: March 30, 2017