Venetoclax for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Myeloid Leukemia+1 MoreVenetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before or has come back.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Acute Recurrent Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 1 year

Year 1
Relapse-free survival
Year 1
Duration of CR/CRi (DoR)
Year 1
Overall survival
Year 1
Event-free survival
Up to 1 year
Incidence of adverse events
Measurable/minimal residual disease (MRD) status
Overall response rate
Rate of CR/CRh
Rate of transfusion-independence

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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%Diabetes mellitus
1%Deafness
1%Sepsis
1%Respiratory tract infection
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%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
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02005471) in the Venetoclax + Rituximab ARM group. Side effects include: Neutropenia with 61%, Diarrhoea with 39%, Nausea with 21%, Upper respiratory tract infection with 21%, Fatigue with 18%.

Trial Design

1 Treatment Group

Treatment (azacitidine, decitabine, venetoclax)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Venetoclax · No Placebo Group · Phase 2

Treatment (azacitidine, decitabine, venetoclax)Experimental Group · 3 Interventions: Azacitidine, Decitabine, Venetoclax · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Decitabine
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?

Brian JonasLead Sponsor
4 Previous Clinical Trials
70 Total Patients Enrolled
AbbVieIndustry Sponsor
836 Previous Clinical Trials
471,750 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,093 Previous Clinical Trials
41,143,300 Total Patients Enrolled
Brian A JonasPrincipal InvestigatorUniversity of California, Davis
3 Previous Clinical Trials
73 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The ability to understand and willingness to sign a written informed consent are required for participation in this study.
WHO recently released new diagnostic criteria for AML
People aged 75 or older, or aged 18-74 with at least one of the following co-morbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 Cardiac history of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) =< 50% or chronic unstable angina Carbon monoxide diffusing capability (DLCO) =< 65% or forced expiratory volume in 1 second (FEV1) =< 65% Creatinine clearance >= 30 mL/min to =< 45 mL/min Moderate hepatic impairment with total bilirubin > 1.
Patients who have a white blood cell count of 25,000 or more cells per cubic millimeter at the start of treatment will be allowed to have leukapheresis and hydroxyurea to meet this criteria.
According to the text, the total bilirubin for subjects aged 18-74 should not exceed 3 times the institution's ULN, except in cases related to AML or Gilbert's syndrome.
The patient in the study had a history of hematologic disorder (like myelodysplastic syndrome) that had caused them to experience HMA failure prior to entering the study
You are allowed to have a prior allogeneic hematopoietic transplant (a transplant using cells from a donor) if it was done at least 3 months prior to enrolling in this study, and you do not have any evidence of active graft versus host disease (GVHD) or a requirement for systemic immune suppression.
The ECOG performance status of a subject is between 0 and 3, with 0 being the best, 3 being the worst, and 2 being the midpoint