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PI3K inhibitor

Copanlisib + Rituximab for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Mark J Roschewski, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function as evidenced by specific laboratory parameters

ECOG performance status 0-2

Must not have

Known lymphomatous involvement of the central nervous system

Uncontrolled Type I or II diabetes despite optimal medical management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 months from study enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if a combination of drugs can attack the cancer cells in people with follicular lymphoma.

Who is the study for?

This trial is for people with untreated Follicular Lymphoma (FL) who need systemic therapy due to symptoms or disease progression. Participants must be at least 8 years old, have good organ function, and not have had previous FL treatments except radiation. They should also agree to use effective contraception.

What is being tested?

The study tests the effectiveness of copanlisib plus rituximab in slowing FL growth. It involves up to 13 cycles of treatment over 28 days each, with both drugs administered through IV infusions at varying intervals.

What are the potential side effects?

Potential side effects include reactions related to IV infusion, changes in blood counts that could affect immunity and clotting, liver enzyme alterations suggesting liver stress or damage, and possible kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organ functions are within normal ranges according to recent tests.

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I can take care of myself and am up and about more than half of the day.

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My lymphoma is confirmed as grade 1-2 or 3a Follicular Lymphoma by NCI standards.

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I am at least 8 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma has spread to my brain or spinal cord.

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My diabetes is not under control despite taking my medication.

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I am currently receiving treatment for another cancer.

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I have severe liver problems.

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I have been treated for an autoimmune disease in the last year.

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I have an active hepatitis B infection.

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I have unstable chest pain.

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I need urgent treatment to reduce my tumor because it's affecting my organ function.

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I do not have HIV or any other immune deficiency.

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I have had lung inflammation treated with steroids, or I currently have lung disease.

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I have an active hepatitis C infection.

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I haven't had major surgery or a serious injury recently.

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My heart condition does not severely limit my daily activities.

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My high blood pressure is not controlled despite taking medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 months from study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30 months from study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 months from study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acheivement of complete response

Secondary study objectives

Continuous complete response rate

Safety of study treatments when given in combination

Side effects data

From 2021 Phase 2 trial • 24 Patients • NCT02631590

75%

Platelet count decreased

75%

Lymphocyte count decreased

71%

Fatigue

71%

White blood cell decreased

67%

Anemia

67%

Neutrophil count decreased

63%

Hypertension

54%

Hyperglycemia

50%

Nausea

46%

Diarrhea

46%

Lipase increased

46%

Anorexia

42%

Alanine aminotransferase increased

42%

Abdominal Pain

33%

Fever

29%

Hyponatremia

25%

Weight loss

25%

Dehydration

25%

Hyperkalemia

25%

Hypotension

25%

Vomiting

25%

Constipation

25%

Rash maculo-papular

21%

Edema limbs

21%

Aspartate aminotransferase increased

21%

Serum amylase increased

17%

Chills

17%

Pain

17%

Alkaline phosphatase increased

17%

Creatinine increased

17%

Thromboembolic event

17%

Sinus tachycardia

17%

Dizziness

13%

Pain in extremity

13%

Generalized muscle weakness

13%

Dyspnea

13%

Blood bilirubin increased

13%

Hypoalbuminemia

13%

Infusion related reaction

13%

Non-cardiac chest pain

13%

Gastrointestinal disorders - Other

13%

Mucositis oral

13%

Sepsis

13%

Upper respiratory infection

13%

Urinary tract infection

13%

Anxiety

13%

Tinnitus

Back pain

Pleural effusion

Cough

Hypoxia

Ascites

Neck pain

Insomnia

Gallbladder obstruction

Bloating

General disorders and administration site conditions -Other

Abdominal distension

Dysphagia

Pruritus

Rash acneiform

Peripheral sensory neuropathy

Infections and infestations - Other

Dysgeusia

Depression

Phlebitis

Neoplasms benign, malignant and unspecified - Other

Colitis

Colonic obstruction

Gastrointestinal disorders -Other

Cholecystitis

Dry mouth

Pancreatitis

Stomach pain

Toothache

Gait disturbance

Infusion site extravasation

Activated partial thromboplastin time prolonged

Blood antidiuretic hormone abnormal

Investigations - Other

Urine output decreased

Hypercalcemia

Hypernatremia

Hyperuricemia

Hypokalemia

Hypomagnesemia

Aspiration

Atelectasis

Epistaxis

Hiccups

Hoarseness

Nasal congestion

Pneumonitis

Postnasal drip

Productive cough

Sore throat

Wheezing

Bone pain

Paroxysmal atrial tachycardia

Pericarditis

Confusion

Acute kidney injury

Ear pain

Cataract

Dry eye

Fracture

Injury, poisoning and procedural complications - Other

Venous injury

Allergic reaction

Hepatic infection

Infections and Infestations - Other

Urinary tract obstruction

Lung infection

Gastroesophageal reflux disease

Malaise

Musculoskeletal and connective tissue disorders - Other

Skin ulceration

Headache

Parathesia

Gallbladder infection

Dry skin

Skin and subcutaneous tissue disorders - Other

Sinus bradycardia

Cystitis noninfective

Hematuria

Renal and urinary disorders - Other

Urine discoloration

100%

80%

60%

40%

20%

Study treatment Arm

Combination Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment2 Interventions

Window of treatment with Copanlisib 60mg via IV for a single 28 day cycle, once weekly for the first 3 weeks and then a 1 week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m2 via IV, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Copanlisib

2016

Completed Phase 2

~130

Rituximab

1999

Completed Phase 4

~2990