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Alkylating agents

Ibrutinib + Rituximab 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

Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria

Previous documentation of biopsy-proven small lymphocytic lymphoma or diagnosis of CLL according to the NCI/IWCLL criteria with specific criteria met

Must not have

Specific gastrointestinal conditions

Currently active hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline and 3, 6, 12, 15, 18, 24, 36 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying ibrutinib and rituximab compared to fludarabine phosphate, cyclophosphamide, and rituximab to see which works better in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Who is the study for?

This trial is for patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Participants should have symptoms like night sweats, weight loss, or anemia and meet specific blood criteria. They must not have had prior treatments for CLL/SLL, active infections, other primary cancers requiring treatment within 2 years, or certain heart conditions.

What is being tested?

The study compares the effectiveness of Ibrutinib plus Rituximab against Fludarabine Phosphate with Cyclophosphamide and Rituximab in treating CLL/SLL. It aims to determine which combination works better at stopping cancer cell growth by either killing cells or helping the immune system attack them.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to cancer cells, such as fever and fatigue; digestive issues; increased risk of infection due to weakened immunity; possible liver function changes; and risks associated with taking capsules if there are pre-existing gastrointestinal conditions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with CLL or SLL.

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I have a confirmed diagnosis of small lymphocytic lymphoma or CLL.

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I am experiencing symptoms related to my disease.

Exclusion Criteria

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

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I have a specific condition affecting my digestive system.

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I have liver problems right now.

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I have a bleeding disorder or hemophilia.

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I do not have recent heart issues, infections, strokes, active hepatitis, or abnormal lab results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline and 3, 6, 12, 15, 18, 24, 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline and 3, 6, 12, 15, 18, 24, 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline and 3, 6, 12, 15, 18, 24, 36 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

Progression-free Survival (PFS) Rate at 3 Years

Secondary study objectives

Overall Survival (OS) Rate at 3 Years

Progression-free Survival (PFS) by Measurable Residual Disease (MDR) Status at 2 Years

The Association Between Baseline Rai Stage and Complete Response (CR) Rate

+2 more

Other study objectives

Association Between Single Nucleotide Polymorphisms (SNPs) and PFS

Collection of Relapse Samples

Distribution of Genetic Abnormalities Before and After Treatment

+3 more

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, rituximab)Experimental Treatment5 Interventions

Patients receive ibrutinib PO QD on days 1-28. Beginning cycle 2, patients also receive rituximab IV over 4 hours on days 1 and 2 of cycle 2, and day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.

Group II: Arm B (rituximab, fludarabine phosphate, cyclophosphamide)Active Control6 Interventions

Patients receive rituximab IV over 4 hours on days 1 and 2 of cycle 1, and day 1 of cycles 2-6. Patients also receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Ibrutinib

2014

Completed Phase 4

~2060