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Kinase Inhibitor

Triple Drug Therapy for Follicular Lymphoma

Phase 2

Recruiting

Led By Joseph M Tuscano

Research Sponsored by Joseph Tuscano

Eligibility Criteria Checklist

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

Must have

A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated

Bulky disease defined as: A nodal or extranodal (except spleen) mass > 7 cm in its greater diameter or, At least 3 nodal or extranodal sites >= 3 cm in diameter

Must not have

Grade 3b follicular lymphoma

Patients who have undergone major surgery within 14 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat patients with previously untreated follicular lymphoma. The drugs may work better together than each one alone.

Who is the study for?

This trial is for adults with previously untreated stage II-IV follicular lymphoma. Participants must have measurable disease, not be pregnant or breastfeeding, and agree to use reliable contraception. They should not have severe illnesses that could interfere with the study, known HIV or hepatitis infections, significant heart conditions, or a history of certain other malignancies.

What is being tested?

The trial tests a combination of three drugs: Obinutuzumab (an immunotherapy), Ibrutinib and Venetoclax (both target enzymes needed for cancer cell growth). It aims to see if using these drugs together is more effective than when they're used separately in treating follicular lymphoma.

What are the potential side effects?

Potential side effects include immune system changes leading to organ inflammation, increased risk of infection due to weakened immunity, digestive issues like nausea or diarrhea, fatigue from anemia or general energy depletion, liver enzyme alterations indicating potential liver damage.

Eligibility Criteria

Inclusion Criteria

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

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I have untreated follicular lymphoma.

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My cancer has a large tumor over 7 cm or at least 3 tumors each over 3 cm.

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I have experienced fever, night sweats, significant weight loss, fatigue from lymphoma, an enlarged spleen, or compression syndrome.

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I have a tumor that is at least 2 cm large, confirmed by imaging tests.

Exclusion Criteria

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

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My condition is Grade 3b follicular lymphoma.

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I had major surgery less than 2 weeks ago.

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I have a known bleeding disorder like von Willebrand's or hemophilia.

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I have not had a stroke or brain bleed in the last 6 months.

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My liver is severely impaired (Child-Pugh class C).

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I haven't taken strong CYP3A4 inhibitors in the last 7 days and don't need them continuously.

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I do not have HIV, active hepatitis B or C, or any serious infection that needed IV antibiotics or hospitalization in the last 4 weeks.

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I am willing and able to follow all study requirements.

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I have a history of PML, HTLV-1, or suspected TB.

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I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.

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I understand the study's purpose and risks and can sign the consent form.

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I do not have active brain or spinal cord lymphoma.

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My follicular lymphoma has transformed into a more aggressive type.

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I am not pregnant, breastfeeding, nor planning to become pregnant or father a child during the study or within 90 days after the last dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete response (CR) rate

Secondary study objectives

CR rate

Duration of response

Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions

+5 more

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574

44%

Neutropenia

35%

Thrombocytopenia

35%

Diarrhea

29%

Cough

24%

Arthralgia

23%

Infusion related reaction

19%

Fatigue

19%

Back pain

19%

Hypertension

17%

Anaemia

17%

Constipation

17%

Pyrexia

16%

Upper respiratory tract infection

15%

Rash maculo-papular

14%

Muscle spasms

14%

Atrial fibrillation

13%

Hyperuricaemia

13%

Nausea

13%

Nasopharyngitis

12%

Insomnia

12%

Urinary tract infection

12%

Oedema peripheral

11%

Conjunctivitis

11%

Asthenia

11%

Pneumonia

11%

Dyspnoea

11%

Vomiting

11%

Pain in extremity

11%

Dizziness

10%

Cataract

10%

Decreased appetite

Spontaneous haematoma

Anxiety

Fall

Rash

Headache

Iron deficiency

Abdominal pain

Dyspepsia

Vision blurred

Pruritus

Bronchitis

Lacrimation increased

Respiratory tract infection

Blood creatine increased

Productive cough

Oropharyngeal pain

Gastrooesophageal reflux disease

Hypokalaemia

Dry eye

Chills

Myalgia

Depression

Dry Skin

Ecchymosis

Onychoclasis

Palpitations

Stomatitis

Peripheral swelling

Epistaxis

Herpes zoster

Increased tendency to bruise

Hyperglycaemia

Musculoskeletal pain

Haematuria

Petechiae

Cellulitis

Contusion

Tremor

Febrile neutropenia

Adenocarcinoma of colon

Acute coronary syndrome

Gastroenteritis

Weight decreased

Septic shock

Femur fracture

Osteoarthritis

Transient ischaemic attack

Cardiac arrest

Angina pectoris

Death

Cerebrovascular accident

Acute kidney injury

Renal failure

Bronchopulmonary aspergillosis

Gastritis

Ischaemic stroke

Compartment syndrome

Inclusion body myositis

Colorectal cancer

Invasive ductal breast carcinoma

Uterine prolapse

Bronchitis chronic

Respiratory failure

Peripheral ischaemia

Haemoptysis

Oesophageal rupture

Pleural effusion

Colorectal cancer metastatic

Concussion

Cardiac failure congestive

Arthritis

Malignant melanoma

Non-small cell lung cancer

Bacterial sepsis

Myelodysplastic syndrome

Leukopenia

Acute myocardial infarction

Pericarditis

Stress cardiomyopathy

Goitre

Haemorrhoids

Impaired gastric emptying

Proctitis

Small intestinal obstruction

Catheter site haematoma

Multi-organ disorder

Cholelithiasis

Abscess

Bursitis infective staphylococcal

Erysipelas

Escherichia sepsis

Escherichia urinary tract infection

Infective aneurysm

Listeria sepsis

Lower respiratory tract infection

Pneumocystis jirovecii pneumonia

Pneumonia bacterial

Pneumonia klebsiella

Prostate infection

Sinusitis fungal

Urosepsis

Jaw fracture

Pubis fracture

Rib fracture

Spinal compression fracture

Thoracic vertebral fracture

Traumatic haematoma

Upper limb fracture

Diabetes mellitus inadequate control

Adenocarcinoma gastric

Basal cell carcinoma

Benign renal neoplasm

Squamous cell carcinoma

Syncope

Acute psychosis

Complete Suicide

Soft tissue infection

Osteoma

Atrial tachycardia

Retinal detachment

Herpes Zoster

Oral herpes

Pharyngitis

Streptococcal bacteraemia

Cardiac failure

Myocardial infarction

Sudden Death

Incisional hernia

Hypercalcaemia

Hypomagnesaemia

Aplastic anaemia

Inguinal hernia

Large intestine polyp

Cerebral ischaemia

Depressed level of consciousness

Confusional state

Nephrolithiasis

Urinary retention

Benign prostatic hyperplasia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

IBR+OB

CLB+OB

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: Treatment (obinutuzumab, venetoclax, ibrutinib)Experimental Treatment3 Interventions

Patients receive obinutuzumab IV over 60 minutes on days 1, 8, and 15 of cycle 1, day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, and 24. Patients also receive venetoclax PO QD on days 1-28 (days 4-28 of cycle 1) and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obinutuzumab

2014

Completed Phase 3

~3470

Ibrutinib

2014

Completed Phase 4

~2060