Study Summary
This trial is testing a new combination of drugs to treat leukemia. The goal is to find out if it is safe and works well.
Eligible Conditions
- Philadelphia-Like Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 12 Secondary · Reporting Duration: Up to 1 year
At day 28
Minimal residual disease (MRD) negativity after induction +/- extended induction
At week 12
Minimal residual disease (MRD) negativity after consolidation
Minimal residual disease (MRD) negativity after consolidation for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL)
Week 4
Complete response (CR) after induction +/- extended induction
Complete response (CR) after induction +/- extended induction for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL)
Composite complete response (CR) (CR/ CR with incomplete hematologic recovery [CRi]/ CR with partial hematologic recovery [CRh]) after induction +/- extended induction
Composite complete response (CR) (CR/ CR with incomplete hematologic recovery [CRi]/ CR with partial hematologic recovery [CRh]) after induction +/- extended induction for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL)
Minimal residual disease (MRD) negativity after induction +/- extended induction for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL)
Week 4
Dose limiting toxicity
Up to 1 year
Complete response (CR) after consolidation
Complete response (CR) after consolidation for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL)
Leukemia-free survival
Overall survival
Day 30
Incidence of adverse events
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%Deafness
1%Respiratory tract infection
1%Sepsis
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 (venetoclax, C10403 regimen)
1 of 1
Experimental Treatment
6 Total Participants · 1 Treatment Group
Primary Treatment: Venetoclax · No Placebo Group · Phase 1
Treatment (venetoclax, C10403 regimen)Experimental Group · 9 Interventions: Methotrexate, Daunorubicin Hydrochloride, Mercaptopurine, Cyclophosphamide, Cytarabine, Prednisone, Vincristine Sulfate, Pegaspargase, Venetoclax · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methopterin
Not yet FDA approved
Daunorubicin
FDA approved
Mercaptopurine
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Cortisone
Not yet FDA approved
Vincristine
FDA approved
Pegaspargase
FDA approved
Venetoclax
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,069 Previous Clinical Trials
41,129,402 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
515 Previous Clinical Trials
2,248,074 Total Patients Enrolled
Ibrahim T AldossPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled
Eligibility Criteria
Age 18 - 54 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Note: Lymphoblastic leukemia is included as long as there is bone marrow involvement.
You have a newly diagnosed disease with ≥ 5% blasts in the marrow.
AST < 2.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated).
You have a white blood cell count less than 25 x 10^9/L prior to initiation of venetoclax.
You have documented informed consent of the participant and/or legally authorized representative.
You must be between 18 and 54 years of age.
You have histologically confirmed B-cell ALL.
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Conditions
Cancer Related
Treatments