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Kinase Inhibitor

Combination Therapy for Chronic Lymphocytic Leukemia

Phase 3

Waitlist Available

Led By Tait D Shanafelt

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

No current use of corticosteroids except for low doses for non-hematologic conditions

No other active primary malignancy

Must not have

Congestive heart failure NYHA Functional Classification III or IV

History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying ibrutinib, obinutuzumab, and venetoclax to treat patients with chronic lymphocytic leukemia.

Who is the study for?

Adults aged 18-70 with chronic lymphocytic leukemia who haven't had prior CLL treatments, have progressive symptoms or blood abnormalities, and meet specific health criteria. They must not be pregnant/breastfeeding, have certain heart conditions or infections, take strong CYP3A inhibitors/inducers, or have other active cancers.

What is being tested?

The trial is testing if adding Venetoclax to Ibrutinib and Obinutuzumab treatment provides better outcomes for chronic lymphocytic leukemia patients than just Ibrutinib and Obinutuzumab. It includes biospecimen collection, CT scans, bone marrow biopsies, and quality-of-life assessments.

What are the potential side effects?

Possible side effects include diarrhea, nausea, low blood cell counts leading to increased infection risk or bleeding problems; fatigue; muscle and bone pain; rash; fever; coughing; shortness of breath. Some may experience liver function changes.

Eligibility Criteria

Inclusion Criteria

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

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I am not currently using corticosteroids, or only using low doses for non-blood related conditions.

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I do not have any other active cancer besides the one being treated.

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I have been diagnosed with CLL or SLL.

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I haven't received specific drug treatments for my CLL or SLL.

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My stomach and intestines work normally.

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I am between 18 and 70 years old.

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I do not have an active blood disorder that destroys red blood cells and requires treatment to suppress my immune system.

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I haven't needed high dose steroids for autoimmune issues.

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I can swallow pills.

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I have worsening bone marrow failure or symptoms due to enlarged lymph nodes, spleen, or liver.

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I am able to get out of my bed or chair and move around.

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My kidney function is good, with a GFR over 40 mL/min.

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My genetic test shows no deletion on chromosome 17.

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My blood cancer type matches CLL.

Exclusion Criteria

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

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I have severe heart failure.

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I have not had a heart attack or severe heart issues in the last 6 months.

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I haven't had any infections needing treatment in the last 14 days.

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I have an ongoing hepatitis C infection.

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I am taking medication that strongly affects liver enzyme activity.

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I have received steroids for cancer treatment within the last week.

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I haven't taken immunosuppressants, except steroids, in the last 28 days.

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I have not received any live vaccines in the last 4 weeks.

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I have a bleeding disorder or hemophilia.

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I have a serious liver condition right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free survival

Secondary study objectives

Incidence of adverse events

Overall survival

Other study objectives

Adherence

FACT-Leu Trial Outcome Index (TOI) score over time

Quality of life (QOL)

Side effects data

From 2022 Phase 3 trial • 201 Patients • NCT03053440

37%

Diarrhoea

32%

Upper respiratory tract infection

29%

Muscle spasms

28%

Contusion

24%

Arthralgia

24%

Hypertension

22%

Oedema peripheral

22%

Anaemia

21%

Epistaxis

20%

Cough

19%

Rash

19%

Fatigue

18%

Back pain

18%

Atrial fibrillation

17%

Urinary tract infection

16%

Neutropenia

16%

Thrombocytopenia

15%

Nausea

15%

Headache

15%

Vomiting

14%

Pneumonia

14%

Dizziness

13%

Haematuria

12%

Peripheral swelling

12%

Pyrexia

12%

Constipation

11%

Localised infection

10%

Pain in extremity

10%

Onychoclasis

10%

Fall

10%

Oropharyngeal pain

10%

Lower respiratory tract infection

10%

Sinusitis

10%

Palpitations

Insomnia

Nasopharyngitis

Hyperuricaemia

Dyspnoea

Haematoma

Skin laceration

Paraesthesia

Dyspepsia

Dry skin

Cellulitis

Conjunctivitis

Skin infection

Iron deficiency

Anxiety

Rhinitis

Cataract

Conjunctival haemorrhage

Pruritus

Hypokalaemia

Syncope

Vision blurred

Abdominal pain

Abdominal pain upper

Nail infection

Neck pain

Purpura

Asthenia

Abdominal discomfort

Chest pain

Gingival bleeding

Mouth ulceration

Stomatitis

Onychomycosis

Rhinorrhoea

Actinic keratosis

Dermatitis

Petechiae

Influenza like illness

COVID-19

Gastroenteritis

Tooth infection

Limb injury

Squamous cell carcinoma of skin

Peripheral sensory neuropathy

Rosacea

Increased tendency to bruise

Gout

Basal cell carcinoma

Folliculitis

Oral herpes

Gastrooesophageal reflux disease

Retinal haemorrhage

Dry mouth

Angina pectoris

Vertigo

Haemorrhoids

Ecchymosis

Sepsis

Chills

Bronchitis

Furuncle

Joint injury

Blood alkaline phosphatase increased

Neutrophil count decreased

Decreased appetite

Joint swelling

Depression

Productive cough

Skin ulcer

Atrial flutter

Hyperglycaemia

Herpes zoster

Bladder transitional cell carcinoma

Abdominal distension

Tinnitus

Rotator cuff syndrome

Sinus bradycardia

Inguinal hernia

Dysphagia

Dry eye

Dysuria

Pollakiuria

Hypoalbuminaemia

Osteoporosis

Erythema

Acute myocardial infarction

Malaise

Cystitis

Alanine aminotransferase increased

Gamma-glutamyltransferase increased

Musculoskeletal chest pain

Seborrhoeic keratosis

Neuralgia

Benign prostatic hyperplasia

Dyspnoea exertional

Nasal congestion

Pneumonitis

Psoriasis

Skin fissures

Skin lesion

Laryngitis

Respiratory tract infection

Bradycardia

Acute kidney injury

Wound infection

Myalgia

Skin toxicity

Ear infection

Paronychia

Osteoarthritis

Pericarditis

Sciatica

Ocular hyperaemia

Nail disorder

Pleural effusion

Rectal haemorrhage

Cholecystitis

COVID-19 pneumonia

Drug withdrawal syndrome

Seasonal allergy

Vitamin D deficiency

Rash maculo-papular

Hypotension

Death

Loss of consciousness

Post procedural haemorrhage

Laryngeal oedema

Stress fracture

Lumbar vertebral fracture

Haemolytic anaemia

Haemorrhagic disorder

Viral infection

Wound infection staphylococcal

Cardiac failure acute

Wheezing

Colitis

Oral blood blister

Upper gastrointestinal haemorrhage

Drug-induced liver injury

Bacterial sepsis

Brain abscess

Device related infection

Gastrointestinal infection

Neurocryptococcosis

Septic shock

Streptococcal bacteraemia

Femoral neck fracture

Femur fracture

Subdural haematoma

Lethargy

Subarachnoid haemorrhage

Chronic kidney disease

Urinary bladder haemorrhage

Prostatitis

Acute pulmonary oedema

Hyponatraemia

Muscular weakness

Rash erythematous

Hyperviscosity syndrome

Melaena

Clostridium difficile infection

Post procedural sepsis

Pyelonephritis

Cerebrovascular accident

Respiratory disorder

Lymphadenopathy

Streptococcal sepsis

Amyloidosis

Influenza

Pneumonia viral

Coronary artery disease

Pericardial haemorrhage

Urosepsis

Spinal stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Ibrutinib

Arm B: Zanubrutinib

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (ibrutinib, obinutuzumab, venetoclax)Experimental Treatment7 Interventions

Patients receive ibrutinib PO daily on days 1-28 and obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 1-28 of cycles 3-14. Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and CT scans before and after treatment and collection of blood throughout the study.

Group II: Arm B (ibrutinib, obinutuzumab)Active Control6 Interventions

Patients receive ibrutinib PO and obinutuzumab as in arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and CT scans before and after treatment and collection of blood throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740