Venetoclax for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Myeloid LeukemiaVenetoclax - Drug
Eligibility
18 - 59
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new treatment for people with leukemia who have not responded to other treatments.

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Study start date to study end date, or death, whichever comes first, up to 4 years

Year 4
Incidence of Minimal Residual Disease (MRD) Negative Responses
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
One Year Event Free Survival
Overall Survival
Remission Duration
Response Rate, measured by the European Leukemia Net definition: (CRMRD-+CR+CRi+MLFS)

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%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
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

Azacitidine and Venetoclax
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Venetoclax · No Placebo Group · Phase 2

Azacitidine and VenetoclaxExperimental Group · 2 Interventions: Venetoclax, Azacitidine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Azacitidine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study start date to study end date, or death, whichever comes first, up to 4 years

Who is running the clinical trial?

AbbVieIndustry Sponsor
833 Previous Clinical Trials
471,073 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,590 Previous Clinical Trials
1,927,202 Total Patients Enrolled
Daniel Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
133 Total Patients Enrolled

Eligibility Criteria

Age 18 - 59 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
You have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
AST ≤ 3.0 × ULN*\n
Subject must have confirmation of non-APL and AML by WHO criteria.