Trial Outcomes & Findings for Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy (NCT NCT02649387)

Last Updated: 2026-02-10

Results Overview

This outcome is summarized by the proportion of patients achieving MRD negative status. A confirmed MRD-negative response is defined as an achievement of MRD-negative status in both the blood and the bone marrow on two consecutive evaluations at least 3 months apart.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

3 years

Results posted on

2026-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Ibrutinib) Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ibrutinib) n=35 Participants Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Age, Continuous	63 years n=4 Participants
Sex: Female, Male Female	11 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=4 Participants
Race (NIH/OMB) White	32 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=35 Participants Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Rate of Confirmed MRD-negative Response	0 proportion of patients

SECONDARY outcome

Timeframe: 5 years

Population: No patients achieved MRD status, thus no patients are evaluable for this outcome measure.

Defined as the time from the earliest date that the patient was noted as having MRD-negative response in both the blood and bone marrow until the first notation of MRD positive disease in the blood or the bone marrow.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 5 years

Assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after the last day of study drug treatment

Will be graded according to the Grading Scale for Hematologic Adverse Events in CLL Studies. The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Defined as the time from the 48-week MRD evaluation until the time of disease progression per the IWCLL criteria or death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No patients achieved MRD status, thus no patients are evaluable for this outcome measure.

Defined as the time from the date of registration to the earliest date that the patient was noted as having MRD-negative response in both the blood and bone marrow

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Defined as the time from the 48-week MRD evaluation until the time of initiation of subsequent treatment for progressive CLL

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Ibrutinib)

Serious events: 16 serious events

Other events: 30 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Ibrutinib) n=35 participants at risk Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Nervous system disorders Intracranial hemorrhage	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Renal and urinary disorders Renal colic	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Vascular disorders Hematoma	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Vascular disorders Hypotension	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Blood and lymphatic system disorders Febrile neutropenia	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Cardiac disorders Atrial fibrillation	8.6% 3/35 • Number of events 3 • Adverse events were followed for 3 years and mortality was followed for 8 years
Gastrointestinal disorders Gastrointestinal disorders - Oth spec	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Gastrointestinal disorders Nausea	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Gastrointestinal disorders Pancreatitis	2.9% 1/35 • Number of events 2 • Adverse events were followed for 3 years and mortality was followed for 8 years
General disorders Death NOS	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
General disorders Fever	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Immune system disorders Allergic reaction	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Infections and infestations Infections and infestations - Oth spec	5.7% 2/35 • Number of events 2 • Adverse events were followed for 3 years and mortality was followed for 8 years
Infections and infestations Lung infection	8.6% 3/35 • Number of events 3 • Adverse events were followed for 3 years and mortality was followed for 8 years
Infections and infestations Skin infection	5.7% 2/35 • Number of events 2 • Adverse events were followed for 3 years and mortality was followed for 8 years
Injury, poisoning and procedural complications Fracture	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Musculoskeletal and connective tissue disorders Arthritis	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Musculoskeletal and connective tissue disorders Myalgia	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Nervous system disorders Headache	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mal, uncpec - Oth spec	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years

Other adverse events

Other adverse events
Measure	Treatment (Ibrutinib) n=35 participants at risk Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Atrial fibrillation	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Gastrointestinal disorders Abdominal pain	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Gastrointestinal disorders Diarrhea	5.7% 2/35 • Number of events 3 • Adverse events were followed for 3 years and mortality was followed for 8 years
General disorders Fatigue	17.1% 6/35 • Number of events 10 • Adverse events were followed for 3 years and mortality was followed for 8 years
Infections and infestations Skin infection	5.7% 2/35 • Number of events 3 • Adverse events were followed for 3 years and mortality was followed for 8 years
Infections and infestations Upper respiratory infection	2.9% 1/35 • Number of events 3 • Adverse events were followed for 3 years and mortality was followed for 8 years
Infections and infestations Wound infection	5.7% 2/35 • Number of events 2 • Adverse events were followed for 3 years and mortality was followed for 8 years
Injury, poisoning and procedural complications Hip fracture	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Injury, poisoning and procedural complications Inj, pois and proced complic - Oth spec	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations Alanine aminotransferase increased	2.9% 1/35 • Number of events 2 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations Aspartate aminotransferase increased	2.9% 1/35 • Number of events 2 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations Investigations - Other, specify	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations Lymphocyte count decreased	8.6% 3/35 • Number of events 5 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations Lymphocyte count increased	25.7% 9/35 • Number of events 135 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations Neutrophil count decreased	28.6% 10/35 • Number of events 33 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations Platelet count decreased	68.6% 24/35 • Number of events 326 • Adverse events were followed for 3 years and mortality was followed for 8 years
Investigations White blood cell decreased	20.0% 7/35 • Number of events 14 • Adverse events were followed for 3 years and mortality was followed for 8 years
Metabolism and nutrition disorders Hypomagnesemia	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Metabolism and nutrition disorders Hyponatremia	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 3/35 • Number of events 8 • Adverse events were followed for 3 years and mortality was followed for 8 years
Musculoskeletal and connective tissue disorders Myalgia	5.7% 2/35 • Number of events 4 • Adverse events were followed for 3 years and mortality was followed for 8 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mal, uncpec - Oth spec	2.9% 1/35 • Number of events 3 • Adverse events were followed for 3 years and mortality was followed for 8 years
Nervous system disorders Headache	8.6% 3/35 • Number of events 3 • Adverse events were followed for 3 years and mortality was followed for 8 years
Nervous system disorders Peripheral sensory neuropathy	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Nervous system disorders Syncope	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Psychiatric disorders Psychiatric disorders - Other, specify	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Skin and subcutaneous tissue disorders Alopecia	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Skin and subcutaneous tissue disorders Rash maculo-papular	2.9% 1/35 • Number of events 1 • Adverse events were followed for 3 years and mortality was followed for 8 years
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	5.7% 2/35 • Number of events 2 • Adverse events were followed for 3 years and mortality was followed for 8 years
Vascular disorders Hypertension	28.6% 10/35 • Number of events 22 • Adverse events were followed for 3 years and mortality was followed for 8 years
Blood and lymphatic system disorders Anemia	40.0% 14/35 • Number of events 59 • Adverse events were followed for 3 years and mortality was followed for 8 years

Additional Information

Asher Alban Chanan Khan

Mayo Clinic

Phone: 904-953-0450

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place