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Proteasome Inhibitor
Carfilzomib for Diffuse Large B-Cell Lymphoma
Phase 1 & 2
Waitlist Available
Led By Brian Hill, MD, PhD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients may have received brief (<15 days) treatment with glucocorticoids and/or 1 cycle of chemotherapy such as R-CHOP [or some component(s) thereof] for the diagnosis of B-cell lymphoma provided they had all necessary staging tests performed prior to R-CHOP including CT and/or PET/CT scans, echocardiogram and bone marrow biopsy. Treatment must occur within 60 days prior to enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after treatment
Awards & highlights
Study Summary
This trial is studying carfilzomib, rituximab, and combination chemotherapy to see how well they work in treating patients with diffuse large B-cell lymphoma.
Eligible Conditions
- Non-Contiguous Diffuse Large B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma
- Adult Diffuse Large Cell Lymphoma
- Diffuse Large Cell Lymphoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase II dose (Phase I)
Secondary outcome measures
Complete Response Rate (Phase II)
Overall Survival (Phase II)
Partial Response Rate (Phase II)
+1 moreSide effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Platelet count decreased
49%
Upper respiratory tract infection
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Diarrhoea
17%
Hyperuricaemia
16%
Blood lactate dehydrogenase increased
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Hypoalbuminaemia
15%
Blood pressure increased
15%
Blood uric acid increased
15%
Lung infection
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
14%
Hyperglycaemia
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Hyponatraemia
11%
Alanine aminotransferase increased
11%
Hypercalcaemia
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Bronchitis
10%
Aspartate aminotransferase increased
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood albumin decreased
8%
Blood phosphorus increased
8%
Hypoproteinaemia
8%
Influenza
7%
Prealbumin decreased
7%
Peripheral swelling
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Nasopharyngitis
7%
Bilirubin conjugated increased
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Thrombocytopenia
6%
Vision blurred
6%
Nausea
6%
Hepatic function abnormal
6%
Respiratory tract infection
6%
Hyperkalaemia
6%
Hypoglycaemia
3%
Acute kidney injury
3%
Plasma cell myeloma
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Pathological fracture
1%
Dysuria
1%
Hypotension
1%
Cardiac failure acute
1%
Spinal compression fracture
1%
Lipoma
1%
Periodontitis
1%
Asthma
1%
Deep vein thrombosis
1%
Myelopathy
1%
Chronic kidney disease
1%
Nerve compression
1%
Otitis media
1%
Soft tissue infection
1%
Cerebral ischaemia
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Pleural effusion
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
1%
Pain
1%
Bronchiolitis
1%
Device related infection
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
Trial Design
1Treatment groups
Experimental Treatment
Group I: rituximab, combination chemotherapy, carfilzomibExperimental Treatment8 Interventions
Participants receive (every 21 day cycle):
Rituximab IV over at least 90 minutes on day 2
Carfilzomib IV over 30 minutes on days 1, and 2
Cyclophosphamide IV over 30-60 minutes on day 3
Doxorubicin hydrochloride IV over 3-5 minutes on day 3
Vincristine sulfate IV over 1 minute on day 3
Prednisone PO on days 3-7 any time
Pegfilgrastim day 4
Acyclovir 2x per day from cycle 1, 6 months after completion of cycle 6
Courses repeat every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Rituximab
1999
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370
Acyclovir
2005
Completed Phase 4
~5180
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin hydrochloride
1989
Completed Phase 3
~530
Vincristine sulfate
2013
Completed Phase 2
~70
Pegfilgrastim
2013
Completed Phase 3
~4410
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
447 Previous Clinical Trials
31,306 Total Patients Enrolled
Brian Hill, MD, PhDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
4 Previous Clinical Trials
92 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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