Venetoclax for Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Leukemia+27 More
Venetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying venetoclax and decitabine to see how well they work in treating acute myeloid leukemia and high-risk myelodysplastic syndrome.

Eligible Conditions
  • Leukemia
  • leukemia
  • Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Leukemia, Myelocytic, Acute
  • Myeloid Leukemia
  • Acute biphenotypic leukemia
  • chronic, recurrent Myelomonocytic Leukemia
  • Mixed Phenotype Acute Leukemia (MPAL)
  • Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Refractory Chronic Myelomonocytic Leukemia
  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
  • Leukemia, Myelomonocytic, Chronic
  • Muscular Dystrophy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia

Study Objectives

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

Baseline
Biomarker analysis
Day 112
Overall response rate (ORR)
Up to 5 years
Disease free survival
Duration of response
Incidence of adverse events
Overall survival

Trial Safety

Safety Progress

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

Other trials for Leukemia

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%Dizziness
6%Hypokalaemia
6%Hyperkalaemia
6%Hypertension
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%Respiratory tract infection
1%Sepsis
1%Skin cancer
1%Oesophageal obstruction
1%Dyspepsia
1%Gastrointestinal haemorrhage
1%Deafness
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

Treatment (decitabine, venetoclax)
1 of 1
Experimental Treatment

400 Total Participants · 1 Treatment Group

Primary Treatment: Venetoclax · No Placebo Group · Phase 2

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

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,488 Total Patients Enrolled
1,478 Trials studying Leukemia
378,256 Patients Enrolled for Leukemia
M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,363 Total Patients Enrolled
437 Trials studying Leukemia
31,990 Patients Enrolled for Leukemia
Marina KonoplevaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
33 Total Patients Enrolled
2 Trials studying Leukemia
33 Patients Enrolled for Leukemia
Abhishek Maiti, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
62 Total Patients Enrolled
1 Trials studying Leukemia
62 Patients Enrolled for Leukemia

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Elderly patients with newly diagnosed AML, BPDCN, or MPAL not eligible for intensive chemotherapy.
You have AML or BPDCN with a history of MDS or CMML and are eligible for treatment at the time of diagnosis of AML regardless of any prior therapy for MDS or CMML.
You have a performance status of 0, 1, 2, or 3.
You have adequate renal function including creatinine < 2.0 unless related to the disease.
ALT < 3 x ULN unless considered due to leukemic involvement.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References