Trial Outcomes & Findings for Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT NCT02824029)
NCT ID: NCT02824029
Last Updated: 2025-02-17
Results Overview
Overall response rate (ORR) defined as the proportion of participants having a complete (CR) and partial (PR) response. A one-sample binomial test will be used to assess ORR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From date of study entry to date of progression or death up to 24 months
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Treatment (Ibrutinib)
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Treatment (Ibrutinib)
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
Didn't receive treatment
|
2
|
|
Overall Study
Patient decision to discontinue treatment
|
3
|
|
Overall Study
Non-compliant
|
5
|
|
Overall Study
Progression of disease
|
15
|
|
Overall Study
Inadequate response to therapy
|
2
|
|
Overall Study
Possible progression per treating physician
|
1
|
Baseline Characteristics
Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Ibrutinib)
n=28 Participants
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
37.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Stage at Enrollment
II
|
4 Participants
n=5 Participants
|
|
Stage at Enrollment
III
|
11 Participants
n=5 Participants
|
|
Stage at Enrollment
IV
|
8 Participants
n=5 Participants
|
|
Stage at Enrollment
Unknown
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of study entry to date of progression or death up to 24 monthsOverall response rate (ORR) defined as the proportion of participants having a complete (CR) and partial (PR) response. A one-sample binomial test will be used to assess ORR.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=21 Participants
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Response Rate (ORR)
|
0.05 Proportion of participants
Interval 0.002 to 0.23
|
SECONDARY outcome
Timeframe: From date of documented tumor response, CR or PR, to date of disease progression or death, up to 24 monthsKaplan-Meier estimate of median DOR will be reported with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=1 Participants
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Duration of Response (DOR)
|
5.6 months
Since only one patient achieved PR, none achieved CR, the confidence interval is not evaluable.
|
SECONDARY outcome
Timeframe: From date of study entry to date of progression or death up to 24 months.Kaplan-Meier estimate of median PFS will be reported with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=21 Participants
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Progression Free Survival (PFS)
|
4.6 months
Interval 1.9 to 6.4
|
Adverse Events
Treatment (Ibrutinib)
Serious events: 5 serious events
Other events: 25 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Treatment (Ibrutinib)
n=26 participants at risk
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Dental: teeth
|
3.8%
1/26 • Number of events 1 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Obstruction, GI
|
3.8%
1/26 • Number of events 1 • From date of study entry to date of progression or death up to 27 months
|
|
Infections and infestations
Infection
|
11.5%
3/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Number of events 1 • From date of study entry to date of progression or death up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.8%
1/26 • Number of events 1 • From date of study entry to date of progression or death up to 27 months
|
Other adverse events
| Measure |
Treatment (Ibrutinib)
n=26 participants at risk
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Edema
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
15.4%
4/26 • Number of events 6 • From date of study entry to date of progression or death up to 27 months
|
|
Cardiac disorders
Palpitations
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Eye disorders
Vision-blurred vision
|
11.5%
3/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Anorexia
|
11.5%
3/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Constipation
|
23.1%
6/26 • Number of events 8 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Diarrhea
|
42.3%
11/26 • Number of events 12 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Gastrointestinal
|
7.7%
2/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
19.2%
5/26 • Number of events 5 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
15.4%
4/26 • Number of events 6 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Nausea
|
42.3%
11/26 • Number of events 20 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Gastrointestinal disorders
Xerostomia
|
11.5%
3/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
General disorders
Constitutional Symptoms
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
General disorders
Fatigue
|
26.9%
7/26 • Number of events 8 • From date of study entry to date of progression or death up to 27 months
|
|
General disorders
Fever
|
11.5%
3/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
General disorders
Insomnia
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
General disorders
Pain
|
23.1%
6/26 • Number of events 7 • From date of study entry to date of progression or death up to 27 months
|
|
General disorders
Syndromes
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Immune system disorders
Allergic rhinitis
|
11.5%
3/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
Infections and infestations
Infection
|
19.2%
5/26 • Number of events 5 • From date of study entry to date of progression or death up to 27 months
|
|
Injury, poisoning and procedural complications
Hemorrhage
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Metabolism and nutrition disorders
AST, SGOT
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Metabolism and nutrition disorders
Creatinine
|
11.5%
3/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue
|
11.5%
3/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
15.4%
4/26 • Number of events 5 • From date of study entry to date of progression or death up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
26.9%
7/26 • Number of events 9 • From date of study entry to date of progression or death up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
11.5%
3/26 • Number of events 3 • From date of study entry to date of progression or death up to 27 months
|
|
Nervous system disorders
Dizziness
|
15.4%
4/26 • Number of events 7 • From date of study entry to date of progression or death up to 27 months
|
|
Nervous system disorders
Mood alteration - Anxiety
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Nervous system disorders
Neuropathy
|
19.2%
5/26 • Number of events 5 • From date of study entry to date of progression or death up to 27 months
|
|
Nervous system disorders
Pain - Head/headache
|
19.2%
5/26 • Number of events 6 • From date of study entry to date of progression or death up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
6/26 • Number of events 6 • From date of study entry to date of progression or death up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
6/26 • Number of events 7 • From date of study entry to date of progression or death up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
7.7%
2/26 • Number of events 2 • From date of study entry to date of progression or death up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/respiratory
|
23.1%
6/26 • Number of events 7 • From date of study entry to date of progression or death up to 27 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
15.4%
4/26 • Number of events 7 • From date of study entry to date of progression or death up to 27 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.4%
4/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
11.5%
3/26 • Number of events 4 • From date of study entry to date of progression or death up to 27 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
6/26 • Number of events 8 • From date of study entry to date of progression or death up to 27 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place