Trial Outcomes & Findings for Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (NCT NCT02129062)

Last Updated: 2017-01-16

Results Overview

ORR is defined as the proportion of participants with complete or partial response. Response definitions of Complete Response (CR): disappearance of leukemia as indicated by \<5% marrow blasts \& absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) \>1000/μL \& platelets \>100,000/μL. C1 extramedullary disease status required. CR with incomplete count recovery (CRi): CR except with ANC \<1000/μL and/or platelets \<100,000/μL. Partial response (PR): improved or no worsening of ALL as indicated by no peripheral blood blasts, neutrophils \>1000/μL, platelets \>100,000μL, and either or both of the following: \>50% decrease in marrow blast percentage, compared to pretreatment value, \& marrow blast percentage ≥ 5% and ≤ 25%. C2 extramedullary disease status. Treatment failures are defined as participants who fail to achieve CR, CRi or PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

3 months after treatment

Results posted on

2017-01-16

Participant Flow

Recruitment Period: April 15, 2014 to November 12, 2015. All recruitment done in medical clinics.

Participant milestones

Participant milestones
Measure	Treatment (Ibrutinib) Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Ibrutinib) Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
Overall Study Death	1
Overall Study Disease Progression	2

Baseline Characteristics

Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ibrutinib) n=3 Participants Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
Age, Continuous	25 years n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after treatment

Population: One of three participants was not evaluable for response.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=2 Participants Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
Objective Response Rate (ORR)	0 percentage of participants

PRIMARY outcome

Timeframe: Up to thirty days after after completion of study treatment anticipated to be 12 weeks for total of 16 weeks

Population: Study terminated early due to slow enrollment, insufficient data . One participant was not evaluable due to early death, other two participants were removed from the study within 30 days of study start due to disease progression prior to scheduled treatment evaluations.

The time measurement from beginning treatment to recurrent or progressive disease is objectively documented. Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups such as age groups, or Philadelphia chromosome-positive versus Philadelphia chromosome-negative B-ALL. Progressive disease is defined as a doubling of the peripheral blasts and an absolute increase of \> 5 x 10\^9/L.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Ibrutinib)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Ibrutinib) n=3 participants at risk Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
General disorders Death	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Blood and lymphatic system disorders Intracranial hemorrhage	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.

Other adverse events

Other adverse events
Measure	Treatment (Ibrutinib) n=3 participants at risk Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
Blood and lymphatic system disorders intracranial hemorrhage	33.3% 1/3 • Number of events 2 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Respiratory, thoracic and mediastinal disorders Dysphagia	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Respiratory, thoracic and mediastinal disorders Lung infection	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Skin and subcutaneous tissue disorders Rash acneiform	66.7% 2/3 • Number of events 2 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • Adverse event collection from start of treatment to 30 days following completion, approximately 16 weeks.

Additional Information

Jan Burger, MD/ UT MD Anderson Associate Professor, Leukemia

UT MD Anderson Cancer Center

Phone: 713-794-4329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60