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Alkylating agents

Copanlisib for Diffuse Large B-Cell Lymphoma

Phase 1
Waitlist Available
Led By Ryan Lynch
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must meet one of the following criteria: Histologically confirmed relapsed/refractory DLBCL or grade 3b follicular lymphoma. Follicular lymphoma that has relapsed within 2 years of primary therapy that included an anti-CD20 antibody in combination with chemotherapy as measured from the date of the last dose of chemotherapy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Previous exposure to other PI3K inhibitors (except copanlisib) is acceptable provided there is no resistance (resistance defined as no response [response defined as partial response (PR) or CR] at any time during therapy), or progressive disease (PD) after any response (PR/CR) or after stable disease within 6 months from the end of the therapy with a PI3K inhibitor Willingness and ability to comply with study and follow-up procedures, and give written informed consent Female subjects of childbearing potential must be surgically sterile, be post-menopausal (per institutional guidelines), or must have a negative pregnancy test within 3 days prior to cycle 1 day 1 and agree to use medically acceptable contraception throughout the study period and for 4 months after the last dose of either study drug. Men of reproductive potential may not participate unless they agree to use medically acceptable contraception throughout the study period and for 4 months after the last dose of either study drug Patients must be expected to receive at least 2 cycles of therapy Patients should have an expected survival if untreated of >= 90 days Total bilirubin =< 1.5 x upper limit of normal (ULN) (< 3 x ULN for patients with Gilbert-Meulengracht syndrome or for patients with cholestasis due to compressive adenopathies of the hepatic hilum) (collected no more than 7 days before starting study treatment) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement by lymphoma (collected no more than 7 days before starting study treatment) Lipase =< 1.5 x ULN (collected no more than 7 days before starting study treatment) Glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula (collected no more than 7 days before starting study treatment). If not on target, this evaluation may be repeated once after at least 24 hours either according to the MDRD abbreviated formula or by 24 hour sampling. If the latter result is within acceptable range, it may be used to fulfill the inclusion criteria instead International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) =< 1.5 x ULN. PT can be used instead of INR if =< 1.5 x ULN (collected no more than 7 days before starting study treatment) Platelet count >= 75,000 /mm^3. For patients with lymphomatous bone marrow infiltration, platelet count >= 50,000 /mm^3 (collected no more than 7 days before starting study treatment) Hemoglobin (Hb) >= 8 g/dl (collected no more than 7 days before starting study treatment). Packed red blood cell transfusion or erythropoietin should not be given less than 7 days before the exam collection Absolute neutrophil count (ANC) >= 1,000/mm^3 (collected no more than 7 days before starting study treatment). For patients with confirmed lymphomatous bone marrow infiltration, ANC count >= 750/mm^3. Myeloid growth factors should not be given less than 7 days before the exam collection
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights

Study Summary

This trial is studying copanlisib and combination chemotherapy to see how well they work in treating patients with diffuse large B-cell lymphoma or follicular lymphoma that has come back.

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Non-Hodgkin's Lymphoma
  • B-Cell Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with a certain type of lymphoma and have undergone certain treatments in the past. You are expected to survive for at least 90 days without treatment. Your liver, kidney, and blood functions are within a certain range. You are willing to comply with the study procedures and use contraception during the study and for a certain period after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT)
Secondary outcome measures
Ability to mobilize an adequate number of CD34+ stem cells for autologous stem cell transplant (ASCT)
Ability to proceed with ASCT
Cell of origin (COO)
+5 more

Side effects data

From 2021 Phase 2 trial • 24 Patients • NCT02631590
75%
Platelet count decreased
75%
Lymphocyte count decreased
71%
White blood cell decreased
71%
Fatigue
67%
Neutrophil count decreased
67%
Anemia
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Lipase increased
46%
Diarrhea
46%
Anorexia
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hyperkalemia
25%
Constipation
25%
Vomiting
25%
Weight loss
25%
Dehydration
25%
Hypotension
25%
Rash maculo-papular
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
21%
Edema limbs
17%
Creatinine increased
17%
Alkaline phosphatase increased
17%
Sinus tachycardia
17%
Chills
17%
Pain
17%
Thromboembolic event
17%
Dizziness
13%
Generalized muscle weakness
13%
Pain in extremity
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Anxiety
13%
Tinnitus
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Dyspnea
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
8%
Back pain
8%
Neck pain
8%
Depression
8%
Gallbladder obstruction
8%
Abdominal distension
8%
Ascites
8%
Bloating
8%
Dysphagia
8%
General disorders and administration site conditions -Other
8%
Cough
8%
Hypoxia
8%
Pleural effusion
8%
Pruritus
8%
Rash acneiform
8%
Infections and infestations - Other
8%
Insomnia
8%
Dysgeusia
8%
Peripheral sensory neuropathy
4%
Pneumonitis
4%
Sore throat
4%
Productive cough
4%
Cataract
4%
Lung infection
4%
Gastrointestinal disorders -Other
4%
Cholecystitis
4%
Infections and Infestations - Other
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Nasal congestion
4%
Postnasal drip
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
4%
Urinary tract obstruction
4%
Bone pain
4%
Musculoskeletal and connective tissue disorders - Other
4%
Gallbladder infection
4%
Paroxysmal atrial tachycardia
4%
Pericarditis
4%
Sinus bradycardia
4%
Ear pain
4%
Dry eye
4%
Fracture
4%
Neoplasms benign, malignant and unspecified - Other
4%
Colitis
4%
Colonic obstruction
4%
Dry mouth
4%
Gastroesophageal reflux disease
4%
Infusion site extravasation
4%
Malaise
4%
Activated partial thromboplastin time prolonged
4%
Blood antidiuretic hormone abnormal
4%
Investigations - Other
4%
Urine output decreased
4%
Hypercalcemia
4%
Hypernatremia
4%
Hyperuricemia
4%
Hypokalemia
4%
Hypomagnesemia
4%
Phlebitis
4%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Skin ulceration
4%
Confusion
4%
Acute kidney injury
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
4%
Injury, poisoning and procedural complications - Other
4%
Gait disturbance
4%
Headache
4%
Parathesia
4%
Venous injury
4%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (copanlisib, R-GCD)Experimental Treatment6 Interventions
Patients receive copanlisib IV and gemcitabine IV on days 1 and 8, carboplatin IV and rituximab IV on day 1, and dexamethasone PO or IV 30-60 minutes prior to chemotherapy on day 1 and PO in AM or 30-60 minutes prior to chemotherapy on days 2-4. Patients also receive pegfilgrastim SC on day 8 or 9. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130
Gemcitabine
2017
Completed Phase 3
~2070
Rituximab
1999
Completed Phase 4
~1880
Pegfilgrastim
2013
Completed Phase 3
~4410
Carboplatin
2014
Completed Phase 3
~6670
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,726 Previous Clinical Trials
1,821,305 Total Patients Enrolled
BayerIndustry Sponsor
2,229 Previous Clinical Trials
25,325,425 Total Patients Enrolled
Ryan LynchPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
4 Previous Clinical Trials
107 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being admitted to this experiment?

"Indeed, the information compiled on clinicaltrials.gov highlights that this medical experiment is in need of enrolment. The trial was first posted on March 31st 2020 and has seen revisions as recent as July 18th 2022. Aspiring participants should note that 21 patients are required across a single site for successful conclusion of the study."

Answered by AI

What evidence exists that demonstrates the safety of Copanlisib for patients?

"As this is a Phase 1 clinical trial, which only has scant research on both safety and efficacy, Copanlisib received an assessed score of 1."

Answered by AI

What clinical applications is Copanlisib most frequently employed for?

"Copanlisib is often used as a primary treatment option, and has been known to effectively treat ophthalmia, sympathetic disorders, therapeutic interventions, and branch retinal vein occlusions."

Answered by AI

Are there other historical experiments that have utilized Copanlisib?

"Currently, there are 2078 ongoing studies into Copanlisib's efficacy. Of these trials, 563 have reached Phase 3 of the trial process with most situated in Majadahonda, Madrid and a total of 95769 participating locations across the world."

Answered by AI

How extensive is the participant base for this clinical trial?

"Affirmative. Clinicaltrials.gov data indicates that this medical trial, initially advertised on March 31st 2020, is still recruiting patients. Currently 21 people are needed to be enrolled from one site location."

Answered by AI
~2 spots leftby Mar 2025