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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Bhagirathbhai Dholaria, M.D.
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Matched (8/8) or mismatched (7/8) related, unrelated HCT
Donor criteria: HLA ≥ 7/8 related or unrelated donors.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial looks at how well ibrutinib works in treating patients with lymphoma that has come back after a donor stem cell transplant. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Mantle Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Hodgkin's Lymphoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival Probability at 12-month Post HCT
Secondary outcome measures
B Cell Subsets and Signaling Assessed by Mass Cytometry
Minimal Residual Disease Assessed by Sequencing
T Cell Repertoire Assessed by IMMUNOSEQ
+1 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%
Onychoclasis
10%
Pain in extremity
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Hyperuricaemia
9%
Nasopharyngitis
9%
Insomnia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dry skin
7%
Dyspepsia
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Conjunctival haemorrhage
6%
Cataract
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Dermatitis
5%
Rhinorrhoea
5%
Petechiae
5%
Mouth ulceration
5%
Onychomycosis
5%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Abdominal discomfort
5%
Chest pain
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Ecchymosis
4%
Haemorrhoids
4%
Vertigo
4%
Sepsis
4%
Angina pectoris
4%
Retinal haemorrhage
4%
Dry mouth
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Erythema
3%
Osteoporosis
3%
Dysuria
3%
Rotator cuff syndrome
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Abdominal distension
3%
Inguinal hernia
3%
Dry eye
3%
Hypoalbuminaemia
3%
Pollakiuria
3%
Acute myocardial infarction
3%
Sinus bradycardia
3%
Dysphagia
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Wheezing
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Haemolytic anaemia
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Lumbar vertebral fracture
1%
Post procedural haemorrhage
1%
Stress fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Laryngeal oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Haemorrhagic disorder
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment2 Interventions
Beginning between 60-90 days post donor stem cell transplant, patients receive ibrutinib PO QD until 1 year post donor stem cell transplant in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,910 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,623 Total Patients Enrolled
Bhagirathbhai Dholaria, M.D.Principal InvestigatorVanderbilt-Ingram Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025