Study Summary
This trial is testing if a combination of two drugs can help control CLL/SLL that has been previously treated.
Eligible Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Up to completion of cycle 24 (each cycle is 28 days)
Day 28
Rate of undetectable (U) minimal residual disease (MRD) in the peripheral blood
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Venetoclax + Rituximab
61%Neutropenia
39%Diarrhoea
21%Upper respiratory tract infection
21%Nausea
18%Fatigue
18%Cough
14%Constipation
14%Anaemia
14%Pyrexia
12%Thrombocytopenia
11%Headache
11%Nasopharyngitis
11%Insomnia
10%Bronchitis
9%Sinusitis
8%Infusion related reaction
8%Back pain
8%Vomiting
8%Pneumonia
7%Rash
7%Pharyngitis
7%Abdominal pain
6%Oedema peripheral
6%Hypokalaemia
6%Dyspnoea
6%Dizziness
6%Lower respiratory tract infection
6%Urinary tract infection
6%Neutrophil count decreased
6%Hyperkalaemia
6%Productive cough
6%Hypertension
6%Arthralgia
5%Alanine aminotransferase increased
5%Pruritus
5%Conjunctivitis
5%Oropharyngeal pain
4%Chills
4%Febrile neutropenia
4%Oral herpes
4%Decreased appetite
2%Influenza
2%Tumour lysis syndrome
2%Muscle spasms
2%Autoimmune haemolytic anaemia
2%Lung infection
2%Squamous cell carcinoma
1%Pancytopenia
1%Myocardial infarction
1%Deafness
1%Hyperpyrexia
1%Peritoneal tuberculosis
1%Urinary tract infection pseudomonal
1%Colorectal cancer
1%Lacunar infarction
1%Erysipelas
1%Disseminated intravascular coagulation
1%Vertigo
1%Oesophageal obstruction
1%Meningitis
1%Moraxella infection
1%Pneumonia influenzal
1%Pneumonia streptococcal
1%Sepsis
1%Viral upper respiratory tract infection
1%Humerus fracture
1%Dehydration
1%Diabetes mellitus
1%Skin cancer
1%Status epilepticus
1%Nephrolithiasis
1%Cervical dysplasia
1%Deep vein thrombosis
1%Eye haemorrhage
1%Sudden cardiac death
1%Uterine haemorrhage
1%Angina pectoris
1%Cardiac failure
1%Ventricular tachycardia
1%Ascites
1%Dyspepsia
1%Gastrointestinal haemorrhage
1%Haemophilus infection
1%Respiratory tract infection
1%Tooth abscess
1%Myelodysplastic syndrome
1%Immune thrombocytopenic purpura
1%Small intestinal obstruction
1%Diverticulitis
1%Herpes zoster
1%Herpes simplex otitis externa
1%Rhinovirus infection
1%Adenocarcinoma gastric
1%Campylobacter gastroenteritis
1%Cystitis
1%Gastroenteritis rotavirus
1%Viral infection
1%Respiratory tract infection fungal
1%Colon cancer
1%Hyperphosphataemia
1%Malignant melanoma
1%Metastatic malignant melanoma
1%Pancreatic carcinoma
1%Prostatic adenoma
1%Acute kidney injury
1%Bronchiectasis
1%Lung disorder
1%Pulmonary embolism
1%Appendicitis
1%Crohn's disease
1%Bile duct obstruction
1%Respiratory tract infection viral
1%Acute respiratory failure
1%Fluid overload
1%Basal cell carcinoma
Trial Design
1 Treatment Group
Pirtobrutinib+venetoclax
1 of 1
Experimental Treatment
44 Total Participants · 1 Treatment Group
Primary Treatment: Pirtobrutinib · No Placebo Group · Phase 2
Pirtobrutinib+venetoclaxExperimental Group · 2 Interventions: Pirtobrutinib, Venetoclax · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2022
Completed Phase 1
~40
Venetoclax
2019
Completed Phase 3
~2100
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to completion of cycle 24 (each cycle is 28 days)
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,827 Previous Clinical Trials
1,792,724 Total Patients Enrolled
244 Trials studying Lymphoma
45,806 Patients Enrolled for Lymphoma
Alessandra Ferrajoli, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
283 Total Patients Enrolled
Philip Thompson, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been taking venetoclax for at least 12 cycles, and a blood test showed there may still be cancer cells present in your body within the last month.
You are 18 years old or older.
You should be able to carry out daily activities without help, or with only a little help.
Your bilirubin levels in the blood should be within normal range, or slightly higher if you have a condition called Gilbert's disease.
Your body must have a certain number of infection-fighting white blood cells (called absolute neutrophil count) without the help of medication.
You have been diagnosed with chronic lymphocytic leukemia (CLL) based on specific criteria established in 2018.
Your kidneys are functioning well enough to filter waste from your blood, which is determined by a blood test called creatinine clearance.
Your liver enzyme levels (ALT and AST) are not too high, unless it is caused by a documented medical condition, in which case they can be slightly higher.
Your blood platelet count is at least 50,000/ul and you have not received a platelet transfusion within the past two weeks.
Your hemoglobin levels are at least 8 mg/dL.
Frequently Asked Questions
Is this research project still open to new participants?
"From what is detailed on clinicaltrials.gov, this particular trial has closed recruitment. The study was first announced on September 30th, 2022 and underwent its last edit on April 7th, 2022. Even though this opportunity to participate has passed, there are 2,954 other trials that are still recruiting patients." - Anonymous Online Contributor
Unverified Answer
Is it possible to experience negative side effects from Pirtobrutinib?
"Pirtobrutinib falls into the category of a phase 2 drug, meaning that while there is some data supporting its safety, there is no evidence yet to suggest that it is effective. Therefore, our team at Power gave it a score of 2." - Anonymous Online Contributor
Unverified Answer