Trial Outcomes & Findings for A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma (NCT NCT03877055)
NCT ID: NCT03877055
Last Updated: 2022-12-14
Results Overview
using the RECIL criteria
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
2 years
Results posted on
2022-12-14
Participant Flow
Participant milestones
| Measure |
Cohort 1
Copanlisib 45 mg; Ibrutinib 560 mg
|
Cohort 2
Copanlisib 60 mg; Ibrutinib 560 mg
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
Copanlisib 45 mg; Ibrutinib 560 mg
|
Cohort 2
n=2 Participants
Copanlisib 60 mg; Ibrutinib 560 mg
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
72 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsusing the RECIL criteria
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Copanlisib 45 mg; Ibrutinib 560 mg
|
Cohort 2
n=2 Participants
Copanlisib 60 mg; Ibrutinib 560 mg
|
|---|---|---|
|
Complete Response
Complete Response
|
3 Participants
|
1 Participants
|
|
Complete Response
Partial Response
|
2 Participants
|
1 Participants
|
|
Complete Response
No Response
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 5 deaths
Cohort 2
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 |
Cohort 1
n=6 participants at risk
Copanlisib 45 mg; Ibrutinib 560 mg
|
Cohort 2
n=2 participants at risk
Copanlisib 60 mg; Ibrutinib 560 mg
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
3/6 • Up to 2 years
|
100.0%
2/2 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
66.7%
4/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
4/6 • Up to 2 years
|
100.0%
2/2 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
General disorders
Fatigue
|
33.3%
2/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 2 years
|
100.0%
2/2 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Belching
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Type 2
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythematous rash (non-macular, non-papular)
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Infections and infestations
Lip infection
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Investigations
Lipase increased
|
33.3%
2/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Weight loss
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Cardiac disorders
Abnormal EKG
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
General disorders
Edema limbs- L ankle
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
General disorders
Fever
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Gastrointestinal disorders
Melena
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle strain, L pectoralis
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral sensory neuropathy
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Tinea pedis
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 2 years
|
50.0%
1/2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
|
Infections and infestations
Wound infection
|
16.7%
1/6 • Up to 2 years
|
0.00%
0/2 • Up to 2 years
|
Additional Information
Dr. Gilles Salles, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-4153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place