Trial Outcomes & Findings for Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (NCT NCT02419469)

NCT ID: NCT02419469

Last Updated: 2018-06-11

Results Overview

Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2018-06-11

Participant Flow

Participant milestones

Measure	Ofatumumab Plus Chemotherapy Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ofatumumab Plus Chemotherapy Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Baseline characteristics by cohort

Measure	Ofatumumab Plus Chemotherapy n=1 Participants Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
Age, Categorical <=18 years	0 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
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 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	0 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	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.

Outcome measures

Measure	Ofatumumab Plus Chemotherapy n=1 Participants Ofatumumab plus chemotherapy. Only one patient enrolled prior to termination.
Event Free Survival (EFS)	NA Participants Participant was lost to follow up.

Adverse Events

Ofatumumab Plus Chemotherapy

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

Rytting,Michael E.,M.D. / PEDIATRICS

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place