Venetoclax for Leukemia
Phase-Based Progress Estimates
Effectiveness
Safety
Leukemia+27 More
Venetoclax - DrugEligibility
18+
All Sexes
What conditions do you have?
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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
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
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%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
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 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
- DiNardo, Courtney D, Abhishek Maiti, Caitlin R Rausch, Naveen Pemmaraju, Kiran Naqvi, Naval G Daver, Tapan M Kadia, et al.. 2020. “10-day Decitabine with Venetoclax for Newly Diagnosed Intensive Chemotherapy Ineligible, and Relapsed or Refractory Acute Myeloid Leukaemia: A Single-centre, Phase 2 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(20)30210-6.
- Kim, Kunhwa, Abhishek Maiti, Sanam Loghavi, Rasoul Pourebrahim, Tapan M. Kadia, Caitlin R. Rausch, Ken Furudate, et al.. 2021. “Outcomes of tp53 ‐mutant Acute Myeloid Leukemia with Decitabine and Venetoclax”. Cancer. Wiley. doi:10.1002/cncr.33689.
- Venugopal, Sangeetha, Abhishek Maiti, Courtney D. DiNardo, Sanam Loghavi, Naval G. Daver, Tapan M. Kadia, Caitlin R. Rausch, et al.. 2021. “Decitabine and Venetoclax for idh1/2 ‐ Mutated Acute Myeloid Leukemia”. American Journal of Hematology. Wiley. doi:10.1002/ajh.26122.
- Maiti, Abhishek, Courtney D. DiNardo, Sa A. Wang, Jeffrey Jorgensen, Tapan M. Kadia, Naval G. Daver, Nicholas J. Short, et al.. 2021. “Prognostic Value of Measurable Residual Disease After Venetoclax and Decitabine in Acute Myeloid Leukemia”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020003717.
- Laribi, Kamel, Alix Baugier de Materre, Mohamad Sobh, Lorenzo Cerroni, Caterina Giovanna Valentini, Tomohiro Aoki, Ritsuro Suzuki, et al.. 2020. “Blastic Plasmacytoid Dendritic Cell Neoplasms: Results of an International Survey on 398 Adult Patients”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020002474.
- Kim, Kunhwa, Abhishek Maiti, Sanam Loghavi, Rasoul Pourebrahim, Tapan M. Kadia, Caitlin R. Rausch, Ken Furudate, et al.. 2021. “Outcomes of tp53 ‐mutant Acute Myeloid Leukemia with Decitabine and Venetoclax”. Cancer. Wiley. doi:10.1002/cncr.33689.
- Venugopal, Sangeetha, Abhishek Maiti, Courtney D. DiNardo, Wei Qiao, Jing Ning, Sanam Loghavi, Naval G. Daver, et al.. 2021. “Prognostic Impact of Conventional Cytogenetics in Acute Myeloid Leukemia Treated with Venetoclax and Decitabine”. Leukemia & Lymphoma. Informa UK Limited. doi:10.1080/10428194.2021.1973675.
- 2018. "Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03404193.
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