Study Summary
This trial is testing the effects of a combination of drugs on patients with a specific type of leukemia. The drugs may work by stopping the growth of cancer cells or by interfering with the ability of cancer cells to grow and spread.
Eligible Conditions
- Acute Lymphoblastic Leukemia
- Chronic Myeloid Leukemia (CML)
- B-Cell Acute Lymphoblastic Leukemia (ALL)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Up to 12 months
Day 32
Incidence of dose-limiting toxicities
Month 12
Duration of complete molecular response (CMR)
Month 12
Overall survival
Month 12
Progression-free survival
Up to 12 months
Distribution of gene mutations
Frequency of BCR-ABL fusion protein subtypes
Frequency of gene mutations
Percent apoptosis (from baseline) following treatment with inhibitors of the various BH3 family member proteins
Percent apoptosis (from baseline) following treatment with the various BH3 family member proteins
Day 90
Incidence of adverse events
Day 28
Rate of complete molecular remission (CMR)
Rate of complete molecular response (uMRD)
up to 12 months
Cell viability percentage
Trial Safety
Safety Progress
Side Effects for
Venetoclax + Rituximab
61%Neutropenia
39%Diarrhoea
21%Nausea
21%Upper respiratory tract infection
18%Fatigue
18%Cough
14%Constipation
14%Anaemia
14%Pyrexia
12%Thrombocytopenia
11%Headache
11%Nasopharyngitis
11%Insomnia
10%Bronchitis
9%Sinusitis
8%Vomiting
8%Infusion related reaction
8%Back pain
8%Pneumonia
7%Rash
7%Pharyngitis
7%Abdominal pain
6%Hypertension
6%Dizziness
6%Hypokalaemia
6%Hyperkalaemia
6%Productive cough
6%Lower respiratory tract infection
6%Neutrophil count decreased
6%Oedema peripheral
6%Urinary tract infection
6%Dyspnoea
6%Arthralgia
5%Alanine aminotransferase increased
5%Conjunctivitis
5%Oropharyngeal pain
5%Pruritus
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%Sepsis
1%Respiratory tract infection
1%Deafness
1%Dyspepsia
1%Oesophageal obstruction
1%Skin cancer
1%Gastrointestinal haemorrhage
1%Urinary tract infection pseudomonal
1%Myocardial infarction
1%Hyperpyrexia
1%Immune thrombocytopenic purpura
1%Cardiac failure
1%Colorectal cancer
1%Moraxella infection
1%Diabetes mellitus
1%Pneumonia streptococcal
1%Deep vein thrombosis
1%Erysipelas
1%Vertigo
1%Eye haemorrhage
1%Pneumonia influenzal
1%Lacunar infarction
1%Myelodysplastic syndrome
1%Ascites
1%Disseminated intravascular coagulation
1%Diverticulitis
1%Tooth abscess
1%Herpes simplex otitis externa
1%Small intestinal obstruction
1%Sudden cardiac death
1%Haemophilus infection
1%Meningitis
1%Peritoneal tuberculosis
1%Dehydration
1%Pancytopenia
1%Angina pectoris
1%Herpes zoster
1%Status epilepticus
1%Ventricular tachycardia
1%Rhinovirus infection
1%Viral upper respiratory tract infection
1%Adenocarcinoma gastric
1%Campylobacter gastroenteritis
1%Cystitis
1%Gastroenteritis rotavirus
1%Viral infection
1%Humerus fracture
1%Respiratory tract infection fungal
1%Colon cancer
1%Cervical dysplasia
1%Hyperphosphataemia
1%Malignant melanoma
1%Nephrolithiasis
1%Uterine haemorrhage
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
Treatment (prednisone, dasatinib, venetoclax, rituximab)
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Venetoclax · No Placebo Group · Phase 1
Treatment (prednisone, dasatinib, venetoclax, rituximab)Experimental Group · 5 Interventions: Venetoclax, Rituximab, Methotrexate, Prednisone, Dasatinib · Intervention Types: Drug, Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Rituximab
FDA approved
Methopterin
Not yet FDA approved
Prednisone
FDA approved
Dasatinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
Who is running the clinical trial?
AbbVieIndustry Sponsor
834 Previous Clinical Trials
471,295 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
894 Previous Clinical Trials
6,831,154 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
208 Previous Clinical Trials
2,089,415 Total Patients Enrolled
Jessica T LeonardPrincipal InvestigatorOHSU Knight Cancer Institute
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:To be eligible, participants must have been diagnosed with B-type acute lymphoblastic leukemia featuring the t(9;22) translocation (Ph+ ALL), confirmed by histology and a bone marrow biopsy completed during screening
Newly diagnosed subjects must have not received any treatments for their ALL, with the exception of steroids (prednisone, dexamethasone), hydrea or intra-thecal methotrexate
Patients with recurrence of illness may not have previously received dasatinib, but treatment utilizing other tyrosine kinase inhibitors is allowed.
You are at least 18 years of age and may be from any gender identity, race, or ethnicity.
Your Eastern Cooperative Oncology Group (ECOG) status is 2 or lower.
You must be able to ingest medication orally.
Your AST level is lower than twice the upper limit of what is considered normal.
Unless leukemic organ involvement is present.
The Alanine aminotransferase concentration in your blood is below the upper limit of normal.
Unless deemed necessary due to leukemic involvement.
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Conditions
Cancer Related
Treatments