Venetoclax for Acute Myeloid Leukemia

Vanderbilt-Ingram Cancer Center, Nashville, TN
Acute Myeloid Leukemia+2 More ConditionsVenetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the combination of venetoclax and selinexor to see how well it works in treating patients with high-risk blood cancers that have come back or do not respond to initial treatment.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Venetoclax
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Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 2 years

At 12 weeks
Overall response rate (expansion)
Up to 2 years
Overall survival
Progression free survival
Up to 28 days
Maximum tolerated dose (escalation)

Trial Safety

Phase-Based Safety

1 of 3

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Venetoclax
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Side Effects for

Venetoclax + Rituximab
61%Neutropenia
39%Diarrhoea
21%Upper respiratory tract infection
21%Nausea
18%Cough
18%Fatigue
14%Constipation
14%Anaemia
14%Pyrexia
12%Thrombocytopenia
11%Insomnia
11%Headache
11%Nasopharyngitis
10%Bronchitis
9%Sinusitis
8%Vomiting
8%Back pain
8%Infusion related reaction
8%Pneumonia
7%Rash
7%Pharyngitis
7%Abdominal pain
6%Urinary tract infection
6%Dyspnoea
6%Neutrophil count decreased
6%Hypokalaemia
6%Hypertension
6%Hyperkalaemia
6%Oedema peripheral
6%Lower respiratory tract infection
6%Productive cough
6%Dizziness
6%Arthralgia
5%Alanine aminotransferase increased
5%Oropharyngeal pain
5%Pruritus
5%Conjunctivitis
4%Febrile neutropenia
4%Chills
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%Status epilepticus
1%Small intestinal obstruction
1%Hyperpyrexia
1%Cystitis
1%Erysipelas
1%Moraxella infection
1%Respiratory tract infection
1%Malignant melanoma
1%Skin cancer
1%Uterine haemorrhage
1%Pancytopenia
1%Humerus fracture
1%Eye haemorrhage
1%Gastrointestinal haemorrhage
1%Pneumonia influenzal
1%Viral upper respiratory tract infection
1%Myelodysplastic syndrome
1%Deep vein thrombosis
1%Cardiac failure
1%Myocardial infarction
1%Dyspepsia
1%Sudden cardiac death
1%Peritoneal tuberculosis
1%Sepsis
1%Urinary tract infection pseudomonal
1%Metastatic malignant melanoma
1%Lacunar infarction
1%Colorectal cancer
1%Deafness
1%Dehydration
1%Ventricular tachycardia
1%Vertigo
1%Meningitis
1%Tooth abscess
1%Nephrolithiasis
1%Cervical dysplasia
1%Immune thrombocytopenic purpura
1%Angina pectoris
1%Disseminated intravascular coagulation
1%Oesophageal obstruction
1%Diverticulitis
1%Pneumonia streptococcal
1%Rhinovirus infection
1%Herpes zoster
1%Ascites
1%Diabetes mellitus
1%Herpes simplex otitis externa
1%Adenocarcinoma gastric
1%Campylobacter gastroenteritis
1%Gastroenteritis rotavirus
1%Viral infection
1%Respiratory tract infection fungal
1%Colon cancer
1%Hyperphosphataemia
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%, Cough with 18%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1 Treatment Group

Treatment (venetoclax, selinexor)
1 of 1

Experimental Treatment

78 Total Participants · 1 Treatment Group

Primary Treatment: Venetoclax · No Placebo Group · Phase 1

Treatment (venetoclax, selinexor)Experimental Group · 2 Interventions: Venetoclax, Selinexor · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Selinexor
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Karyopharm Therapeutics IncIndustry Sponsor
85 Previous Clinical Trials
8,015 Total Patients Enrolled
Sanjay MohanLead Sponsor
1 Previous Clinical Trials
51 Total Patients Enrolled
AbbVieIndustry Sponsor
871 Previous Clinical Trials
479,129 Total Patients Enrolled
Michael ByrneLead Sponsor
Sanjay Mohan, MDPrincipal InvestigatorVanderbilt Medical Center
1 Previous Clinical Trials
51 Total Patients Enrolled
Michael Byrne, DOPrincipal Investigator - Vanderbilt Medical Center
Vanderbilt-Ingram Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor thinks you will live for at least 12 more weeks.
References

Frequently Asked Questions

Are there any unfilled slots for volunteers in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment has been open for recruitment since June 21st 2019 and was most recently updated on August 12th 2022. 78 individuals must be enlisted from 4 distinct medical centres." - Anonymous Online Contributor

Unverified Answer

Have any other investigational trials been conducted with Venetoclax?

"Venetoclax, which was initially explored in 2014 at Children's Healthcare of Atlanta, has had 80 trials completed to date. Currently, there are 264 ongoing studies across the world - many taking place in Cleveland, Ohio." - Anonymous Online Contributor

Unverified Answer

How many participants are joining this research endeavor?

"Karyopharm Therapeutics Inc will manage the study from University Hospitals of Cleveland and Roswell Park Cancer Center. A total of 78 patients that satisfy the specified criteria must be enrolled to ensure its success." - Anonymous Online Contributor

Unverified Answer

How many centers are currently overseeing this clinical trial?

"This clinical trial is being conducted at University Hospitals of Cleveland in Cleveland, Ohio, Roswell Park Cancer Center in Buffalo, New York and the University of Texas Southwestern Medical Centre in Dallas. Additionally, there are 4 other sites where this research will take place." - Anonymous Online Contributor

Unverified Answer

Is this clinical experiment pioneering a new approach?

"Venetoclax has been under research since 2014, when Karyopharm Therapeutics Inc. conducted the inaugural clinical trial with a participant pool of 16 people. It then received Phase 1 drug approval and is now subject to 264 studies in 1284 cities across 48 nations." - Anonymous Online Contributor

Unverified Answer

What medical conditions is Venetoclax commonly employed to treat?

"Venetoclax has been used in therapeutic procedures and is known to be effective for small lymphocytic lymphoma, chronic lymphycytic leukemia (CLL), and intractable multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Is Venetoclax a reliable approach to treatment with minimal risk?

"As it is a Phase 1 trial, which has limited evidence of efficacy and safety, our experts at Power rate the security of Venetoclax with a score of 1." - 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.

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