Trial Outcomes & Findings for Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma (NCT NCT02207062)

NCT ID: NCT02207062

Last Updated: 2025-01-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2025-01-07

Participant Flow

Participant milestones

Measure	Treatment (Ibrutinib) Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	Treatment (Ibrutinib) n=20 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Measure	Treatment (Ibrutinib) n=18 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Response Rate (Combined Complete Response + Partial Response)	6 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Measure	Treatment (Ibrutinib) n=18 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Complete Response Rate	2 Participants

SECONDARY outcome

Timeframe: >12 months

Outcome measures

Measure	Treatment (Ibrutinib) n=20 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Disease Control Rate	4 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Measure	Treatment (Ibrutinib) n=20 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Survival	22.4 months Interval 7.5 to 36.4

SECONDARY outcome

Timeframe: Time from first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years

Progression-free survival will be calculated using assessments by investigators. Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).

Outcome measures

Measure	Treatment (Ibrutinib) n=20 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Progression-free Survival	4.1 months Interval 2.4 to 6.2

SECONDARY outcome

Timeframe: Up to 5 years

Participants with a histology of follicular lymphoma at diagnosis achieving at least a partial response to treatment.

Outcome measures

Measure	Treatment (Ibrutinib) n=18 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Response Rate Relative to the Underlying B-cell Histology	4 Participants

SECONDARY outcome

Timeframe: Up to 5 years

The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to classify and grade toxicities. Count of participants who stopped ibrutinib due to toxicities.

Outcome measures

Measure	Treatment (Ibrutinib) n=20 Participants Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Tolerability of Chronic Ibrutinib Therapy	1 Participants

Adverse Events

Treatment (Ibrutinib)

Serious events: 7 serious events

Other events: 20 other events

Deaths: 14 deaths

Serious adverse events

Measure	Treatment (Ibrutinib) n=20 participants at risk Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Cardiac disorders Pericarditis	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Cardiac disorders Atrial Fibrillation	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Musculoskeletal and connective tissue disorders Groin Pain	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Mucositis	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Esophagitis	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Musculoskeletal and connective tissue disorders Pain	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Cardiac disorders Acute Myocardial Infarction	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Abdominal Pain	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Infections and infestations Flu-like symptoms	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
General disorders Clamminess	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
General disorders Fatigue	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Cardiac disorders Ventricular arrythmia	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Cardiac disorders CHF Exacerbation	5.0% 1/20 • Number of events 1 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.

Other adverse events

Measure	Treatment (Ibrutinib) n=20 participants at risk Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Ibrutinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Investigations Alanine aminotransferase increased	15.0% 3/20 • Number of events 6 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Metabolism and nutrition disorders Anorexia	10.0% 2/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Investigations Aspartate aminotransferase increased	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Cardiac disorders Atrial Fibrillation	15.0% 3/20 • Number of events 4 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Musculoskeletal and connective tissue disorders Back Pain	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Injury, poisoning and procedural complications Bruising	60.0% 12/20 • Number of events 13 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Constipation	20.0% 4/20 • Number of events 5 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	15.0% 3/20 • Number of events 6 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Diarrhea	30.0% 6/20 • Number of events 7 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Nervous system disorders Dizziness	15.0% 3/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Dry Mouth	10.0% 2/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
General disorders Edema Limbs	20.0% 4/20 • Number of events 7 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.0% 3/20 • Number of events 5 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Esophagitis	10.0% 2/20 • Number of events 5 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
General disorders Fatigue	55.0% 11/20 • Number of events 12 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
General disorders Fever	10.0% 2/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Loose Stools	10.0% 2/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Infections and infestations Cold-Like Symptoms	10.0% 2/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Nervous system disorders Headache	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Vascular disorders Hypertension	15.0% 3/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Metabolism and nutrition disorders Hypokalemia	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Mucositis oral	10.0% 2/20 • Number of events 4 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Nausea	20.0% 4/20 • Number of events 5 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	15.0% 3/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Nervous system disorders Peripheral sensory neuropathy	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Skin and subcutaneous tissue disorders Pruritus	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	15.0% 3/20 • Number of events 5 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Respiratory, thoracic and mediastinal disorders Bronchitis	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Skin and subcutaneous tissue disorders Brittle nails	15.0% 3/20 • Number of events 3 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Respiratory, thoracic and mediastinal disorders Sore throat	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Infections and infestations Upper respiratory infection	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Renal and urinary disorders Urinary urgency	10.0% 2/20 • Number of events 2 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.
Gastrointestinal disorders Vomiting	20.0% 4/20 • Number of events 6 • Adverse events will be collected from the time the consent is signed until 30 days following the last dose of study drug, an average of 18 months. All-Cause Mortality assessed up to 5 years.

Additional Information

Dr. Ajay Gopal, Professor

University of Washington

Phone: 206-606-2037

Email: agopal@uw.edu

Results disclosure agreements

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