Trial Outcomes & Findings for Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL) (NCT NCT00941928)

NCT ID: NCT00941928

Last Updated: 2014-05-22

Results Overview

TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2014-05-22

Participant Flow

Recruitment Period: July 14, 2009 to December 6, 2010. All recruitment occurred at The University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Measure	Haploidentical NK Cells + Epratuzumab Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m\^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m\^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Haploidentical NK Cells + Epratuzumab Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m\^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m\^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
Overall Study Withdrawal by Subject	1
Overall Study Disease Progression	1

Baseline Characteristics

Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)

Baseline characteristics by cohort

Measure	Haploidentical NK Cells + Epratuzumab n=2 Participants Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m\^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m\^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
Age, Continuous	11 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Both participants had recurrent disease before single month assessment therefore no data was analyzed. Study was terminated early due to slow accrual.

TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Minimum of 1 year, or until disease progression or death

Number of surviving participants without disease progression or death for any reason at one year post treatment.

Outcome measures

Outcome data not reported

Adverse Events

Haploidentical NK Cells + Epratuzumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Haploidentical NK Cells + Epratuzumab n=2 participants at risk Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m\^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m\^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
General disorders nausea	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Gastrointestinal disorders vomitting	50.0% 1/2 • Number of events 1 • 1 year and 1 month
General disorders chills	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Musculoskeletal and connective tissue disorders pain	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Gastrointestinal disorders diarrhea	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Metabolism and nutrition disorders creatinine phosphokinase increased	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Musculoskeletal and connective tissue disorders myositis	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Infections and infestations infection	100.0% 2/2 • Number of events 2 • 1 year and 1 month
Cardiac disorders hypertension	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Renal and urinary disorders cystitis	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Gastrointestinal disorders hemorrhage, GU	50.0% 1/2 • Number of events 1 • 1 year and 1 month
Musculoskeletal and connective tissue disorders muscle weakness	50.0% 1/2 • Number of events 1 • 1 year and 1 month

Additional Information

Anna Franklin, MD, Assistant Professor

University of Texas MD Anderson Cancer Center

Phone: 713-792-3497

Email: rnjackso@mdanderson.org

Results disclosure agreements

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