Blinatumomab Bridging Therapy
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04556084|
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia Refractory B Acute Lymphoblastic Leukemia Relapsed B-cell Acute Lymphoblastic Leukemia||Drug: Blinatumomab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blinatumomab Bridging Therapy in High-Risk B-Acute Lymphoblastic Leukemia: A Phase 2 Study|
|Actual Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2024|
Up to 2 cycles of continuous infusion blinatumomab will be given based on the end of Cycle 1 disease response. Cycle 2 of blinatumomab can be given to subjects who have achieved remission (< 5% marrow blasts) after Cycle 1 but have persistent disease identified by multi-parameter flow cytometry (minimal residual disease (MRD) positive ≥ 0.01%) after Cycle 1.
Blinatumomab will be given as a 28-day continuous infusion with 14-days in between Cycle 1 and Cycle 2 as per the package insert and FDA approved labeling.
Patient weight greater than or equal to 45kg will receive 28 mcg/day
Patient weight less than 45kg will receive 15 mcg/m2/day
- Percentage of Subjects in CR [ Time Frame: 42 Months ]The primary efficacy variable is the percent of subjects that remain in Complete Remission (CR) after completion of 1 or 2 cycles of blinatumomab.
- Percentage of Subjects FC-MRD Negative [ Time Frame: 42 Months ]The primary efficacy variable is the percent of subjects that become Flow Cytometry-MRD negative (FC-MRD negative) < 0.01% after completion of 1 or 2 cycles of blinatumomab.
- Percentage of Subjects that HTS-MRD Negative [ Time Frame: 42 Months ]The percent of subjects that achieve MRD negative by molecular High-Throughput Deep Sequencing (HTS-MRD negative) (MRD undetectable) after completion of 1 to 2 cycles of Blinatumomab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556084
|Contact: Amberley Kemic, RNemail@example.com|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Michael Burke, MD 414-955-4170 firstname.lastname@example.org|
|Study Chair:||Michael Burke, MD||Medical College of Wisconsin|