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Corticosteroid
Venetoclax + Ponatinib + Dexamethasone for Leukemia
Phase 1 & 2
Waitlist Available
Led By Farhad Ravandi-Kashani
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with relapsed/refractory Ph-positive ALL or lymphoid blast phase CML (either t(9;22) and/or BCR-ABL1 positive by fluorescent in situ hybridization or polymerase chain reaction), including prior therapy with at least one Bcr-Abl tyrosine kinase inhibitor
Performance status =< 3 Eastern Cooperative Oncology Group (ECOG scale)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing the combination of venetoclax, ponatinib, and dexamethasone to treat participants with relapsed or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.
Who is the study for?
This trial is for people with a specific type of leukemia that has returned or isn't responding to treatment. They must have tried at least one Bcr-Abl tyrosine kinase inhibitor, be able to swallow pills, and have decent organ function and performance status. Pregnant women, those with recent pancreatitis, uncontrolled infections or heart disease, high triglycerides, or who've taken certain drugs recently can't join.Check my eligibility
What is being tested?
The study is testing the best dose of venetoclax combined with ponatinib and dexamethasone in treating acute lymphoblastic leukemia (ALL) or chronic myelogenous leukemia (CML) that's positive for Philadelphia chromosome/BCR-ABL. It aims to find out how well these drugs work together to stop cancer cells from growing.See study design
What are the potential side effects?
Possible side effects include issues related to chemotherapy like nausea, fatigue, risk of infection; ponatinib may cause problems such as blood clots or liver damage; dexamethasone might lead to increased appetite, mood changes, trouble sleeping.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia has returned or didn't respond to treatment, and it's positive for a specific genetic change.
Select...
I can take care of myself but can't do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of venetoclax when given in combination with ponatinib and dexamethasone (Phase I)
Overall response rate
Secondary outcome measures
Incidence of adverse events evaluated according to NCI Common Toxicity Criteria
Median time to allogeneic stem cell transplant (ASCT)
Overall survival (OS)
+3 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ponatinib, venetoclax, dexamethasone, rituximab)Experimental Treatment4 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Ponatinib
FDA approved
Rituximab
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,791 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,656 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
695 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken experimental cancer drugs in the last week, or I've fully recovered from their side effects.I do not have an uncontrolled serious infection.I can swallow.I have had pancreatitis within the last year or suffer from chronic pancreatitis.I have another cancer that is expected to affect my survival within a year.I am not on medication known to cause severe heart rhythm problems, or I can switch.My leukemia has returned or didn't respond to treatment, and it's positive for a specific genetic change.I can take care of myself but can't do heavy physical work.I do not have serious heart or blood vessel problems.I have not taken strong or moderate CYP3A inhibitors or inducers in the last 3 days.I am not pregnant or breastfeeding and will use birth control during the study.I have been treated with venetoclax before, but ponatinib treatment is okay.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I do not have severe heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ponatinib, venetoclax, dexamethasone, rituximab)
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities currently available for enrolment in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this trial began recruiting on June 26th 2018 and is still seeking applicants as of October 31st 2022. 38 participants need to be signed up from a single medical facility."
Answered by AI
What conditions typically necessitate the utilization of Venetoclax?
"Venetoclax is typically prescribed to help manage ophthalmia, sympathetic. Additionally, this medication has also shown potential in treating branch retinal vein occlusion and macular edema as well as certain communicable diseases."
Answered by AI
How many participants are engaged in this research endeavor?
"Affirmative. According to the information on clinicaltrials.gov, this trial is currently recruiting patients that had been initially posted on June 26th 2018 and recently updated in October of 2022. 38 individuals will be accepted at one medical centre."
Answered by AI
What previous experiments involving Venetoclax have been undertaken?
"Presently, 1132 trials dedicated to Venetoclax are underway. 251 of these experiments have reached the advanced Phase 3 stage. The majority of studies for this medication take place in Joliet, Illinois; however, an expansive 38520 sites globally are running trials with it as well."
Answered by AI
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