Trial Outcomes & Findings for Blinatumomab Bridging Therapy for BALL (NCT NCT04556084)

Last Updated: 2025-05-13

Results Overview

The primary efficacy variable is the percent of subjects that remain in Complete Remission (CR) after completion of 1 or 2 cycles of blinatumomab. Complete remission was defined as \<5% blasts in the bone marrow. Complete remission was further defined as minimal residual disease (MRD) positive (\>/= to 0.01%) or MRD negative (\<0.01%) as measured by flow cytometry of the bone marrow.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

1 or 2 Months depending on the number of cycles of blinatumomab

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Blinatumomab 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: 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
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blinatumomab Bridging Therapy for BALL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blinatumomab n=2 Participants 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: 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
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Peripheral White Blood Cell Count (from initial diagnosis)	4.7 10*3 cells/mcL n=5 Participants
CNS Status (from initial diagnosis) CNS I	2 Participants n=5 Participants
CNS Status (from initial diagnosis) CNS II	0 Participants n=5 Participants
CNS Status (from initial diagnosis) CNS III	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 or 2 Months depending on the number of cycles of blinatumomab

Outcome measures

Outcome measures
Measure	Blinatumomab n=2 Participants 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: 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 Complete Remission (CR)	100 percentage of patients MRD negative

PRIMARY outcome

Timeframe: 1 to 2 Months depending on the number of cycles of blinatumomab

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.

Outcome measures

Outcome measures
Measure	Blinatumomab n=2 Participants 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: 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 Flow Cytometry (FC) -Minimal Residual Disease (MRD) Negative Defined as <0.01% Leukemia	100 percent of participants FC-MRD Negative

SECONDARY outcome

Timeframe: After completion of Blinatumomab bridging therapy (1 participant's course consisted of 1 cycle, the other participant's course consisted of 2 cycles)

The percent of subjects that achieve MRD negative by molecular High-Throughput Deep Sequencing (HTS-MRD negative) (MRD undetectable) after completion of Blinatumomab bridging therapy, which may consist of 1 to 2 cycles of Blinatumomab.

Outcome measures

Outcome measures
Measure	Blinatumomab n=2 Participants 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: 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 That Are High-Throughput Deep Sequencing (HTS)-Minimal Residual Disease (MRD) Negative Defined as Undetectable	100 percentage of patients MRD negative

Adverse Events

Blinatumomab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Burke

Medical College of Wisconsin

Phone: 4149554198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place