Venetoclax for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TXAcute Myeloid LeukemiaVenetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a combination of drugs as a potential treatment for acute myeloid leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Venetoclax
1
Venetoclax
1
Venetoclax

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Year 5
Disease-free survival (DFS)
Overall survival (OS)
Up to 5 years
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Overall response rate
Day 28
Rate of complete response (CR/complete response with incomplete recovery [CRi])

Trial Safety

Safety Progress

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

Similar Trials

1
Venetoclax
1
Venetoclax
1
Venetoclax

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%Pharyngitis
7%Rash
7%Abdominal pain
6%Oedema peripheral
6%Hyperkalaemia
6%Productive cough
6%Hypokalaemia
6%Neutrophil count decreased
6%Dizziness
6%Lower respiratory tract infection
6%Dyspnoea
6%Urinary tract infection
6%Hypertension
6%Arthralgia
5%Pruritus
5%Alanine aminotransferase increased
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%Haemophilus infection
1%Meningitis
1%Pneumonia influenzal
1%Pneumonia streptococcal
1%Respiratory tract infection
1%Sepsis
1%Tooth abscess
1%Deep vein thrombosis
1%Oesophageal obstruction
1%Hyperpyrexia
1%Dehydration
1%Ascites
1%Angina pectoris
1%Gastrointestinal haemorrhage
1%Erysipelas
1%Viral upper respiratory tract infection
1%Diabetes mellitus
1%Colorectal cancer
1%Cervical dysplasia
1%Eye haemorrhage
1%Sudden cardiac death
1%Urinary tract infection pseudomonal
1%Lacunar infarction
1%Disseminated intravascular coagulation
1%Uterine haemorrhage
1%Peritoneal tuberculosis
1%Humerus fracture
1%Dyspepsia
1%Nephrolithiasis
1%Myelodysplastic syndrome
1%Immune thrombocytopenic purpura
1%Ventricular tachycardia
1%Deafness
1%Small intestinal obstruction
1%Diverticulitis
1%Herpes zoster
1%Status epilepticus
1%Pancytopenia
1%Cardiac failure
1%Myocardial infarction
1%Vertigo
1%Herpes simplex otitis externa
1%Moraxella infection
1%Skin cancer
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
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%, Upper respiratory tract infection with 21%, Nausea with 21%, Fatigue with 18%.

Trial Design

1 Treatment Group

Treatment (cladribine, cytarabine, venetoclax, azacitidine)
1 of 1

Experimental Treatment

145 Total Participants · 1 Treatment Group

Primary Treatment: Venetoclax · No Placebo Group · Phase 2

Treatment (cladribine, cytarabine, venetoclax, azacitidine)Experimental Group · 4 Interventions: Venetoclax, Cladribine, Cytarabine, Azacitidine · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Cladribine
FDA approved
Cytarabine
FDA approved
Azacitidine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,827 Previous Clinical Trials
1,792,702 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,138 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What is the official stance of the FDA on Venetoclax?

"There is some clinical data supporting Venetoclax's safety, but none demonstrating its efficacy; it received a score of 2." - Anonymous Online Contributor

Unverified Answer

Are people with the relevant health condition able to participate in this trial right now?

"Yes, this study is still looking for individuals to participate. The listing on clinicaltrials.gov shows that the trial was first posted on October 25th 2018 and edited September 19th 2020." - Anonymous Online Contributor

Unverified Answer

Can you name a few other studies where Venetoclax has been used?

"Venetoclax is being investigated in 572 active clinical trials, the majority of which are in Phase 3. Although most of the research for Venetoclax is taking place in Edmonton, Alberta, there are 19891 total locations running clinical trials for this medication." - Anonymous Online Contributor

Unverified Answer

For what ailments is Venetoclax commonly prescribed?

"Venetoclax has many potential applications, including the treatment of small lymphocytic lymphoma, malignant neoplasms, hairy cell leukemia, and multiple sclerosis." - Anonymous Online Contributor

Unverified Answer

How many individuals are participating in this test?

"That is correct, the online clinicaltrials.gov registry currently lists this trial as recruiting patients. The listing includes the date when the study was first posted (10/25/2018) as well as the most recent edit (9/19/2022). This particular research project is only enrolling 85 participants at a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top