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Bruton's Tyrosine Kinase (BTK) Inhibitor
PCI-32765 for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Inhye Ahn, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment drug, PCI-32765, to see if it can treat chronic lymphocytic leukemia and small lymphocytic lymphoma in elderly people and people with 17p deletion.
Who is the study for?
This trial is for adults with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. It's specifically for those over 65, or at least 18 with a genetic abnormality called 17p deletion. Participants must be able to swallow capsules and agree to use contraception if they can have children.Check my eligibility
What is being tested?
The trial tests PCI-32765, a new drug for treating CLL/SLL in older patients and those with the 17p deletion who often don't do well on standard treatments. Patients take daily capsules for six cycles and may continue if beneficial without severe side effects.See study design
What are the potential side effects?
While not explicitly listed, potential side effects of PCI-32765 could include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver or kidney function issues based on exclusion criteria related to organ functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate at 6 Months
Side effects data
From 2022 Phase 3 trial • 201 Patients • NCT0305344037%
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%
Nasopharyngitis
9%
Hyperuricaemia
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%
Cataract
6%
Conjunctival haemorrhage
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%
Stomatitis
5%
Actinic keratosis
5%
Gingival bleeding
5%
Rhinorrhoea
5%
Dermatitis
5%
Onychomycosis
5%
Mouth ulceration
5%
Petechiae
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%
Vertigo
4%
Haemorrhoids
4%
Ecchymosis
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%
Bladder transitional cell carcinoma
3%
Rotator cuff syndrome
3%
Dysuria
3%
Pollakiuria
3%
Abdominal distension
3%
Dry eye
3%
Inguinal hernia
3%
Hypoalbuminaemia
3%
Tinnitus
3%
Osteoporosis
3%
Erythema
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%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Wound infection staphylococcal
1%
Cardiac failure acute
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%
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
2Treatment groups
Experimental Treatment
Group I: Elderly greater than 65Experimental Treatment1 Intervention
Group II: 17p DeletioinExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,833 Previous Clinical Trials
47,306,410 Total Patients Enrolled
88 Trials studying Leukemia
10,480 Patients Enrolled for Leukemia
Inhye Ahn, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
2 Previous Clinical Trials
61 Total Patients Enrolled
2 Trials studying Leukemia
61 Patients Enrolled for Leukemia
Andy Itsara, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Leukemia
29 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never taken PCI 32765 or any BTK inhibitors.I need to take warfarin for blood thinning.I need medication that strongly affects liver enzymes.I am not pregnant, breastfeeding, and willing to follow birth control measures.I understand the study's purpose and can give informed consent.I haven't had any CLL treatments like chemotherapy in the last 4 weeks.I am HIV positive.My CLL has transformed into a more aggressive form.I am 65 or older and need treatment.I am over 18 and have cancer with specific genetic changes.I have a confirmed diagnosis with high B-cell counts or confirmed lymph node involvement.I am under 18 years old.I have an autoimmune blood disorder treated with steroids.My liver function tests are higher than normal, but it's not because of Gilbert's disease or liver infiltration.My kidney function is reduced with high creatinine or low GFR.I don't have any severe illnesses that could affect my safety in the study or interfere with the study drug.I am not currently on high-dose steroids or undergoing cancer treatments.I have an active Hepatitis B infection.
Research Study Groups:
This trial has the following groups:- Group 1: Elderly greater than 65
- Group 2: 17p Deletioin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has PCI 32765 been permitted by the FDA?
"According to Power's safety scale, PCI 32765 scored a 2 due to the presence of Phase 2 trial data indicating some level of security; however, there is no evidence validating its efficacy."
Answered by AI
Is the enrollment process for this trial still available to individuals?
"Unfortunately, this trial is no longer recruiting participants. Initially posted on November 28th 2011 and last updated December 2nd 2021, the study has successfully been completed. Nevertheless, there are over 3000 other studies searching for candidates at present."
Answered by AI
What is the numerical extent of individuals engaging in this research?
"At this moment, no new patients are being sought for this clinical trial. It was initially posted on November 28th 2011 and the last edit occurred December 2nd 2021. Alternatively, there are currently 2864 trials accepting participants with a diagnosis of leukemia and 155 studies enrolling those administered PCI 32765 as part of their treatment plan."
Answered by AI
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