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Antimetabolite
Venetoclax + Chemotherapy for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Courtney DiNardo
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
Only patients who are relapsed, refractory, or intolerant of standard AML therapy will be eligible for Part 1 (minimum of 1 prior line of AML-directed therapy)
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug, venetoclax, to see if it is effective and has manageable side effects when given with standard chemotherapy drugs to patients with newly diagnosed or recurrent acute myeloid leukemia.
Who is the study for?
This trial is for adults with newly diagnosed or stubborn acute myeloid leukemia (AML) who can perform daily activities with ease to moderate difficulty. They must have acceptable liver and kidney function, understand the study, and use effective contraception if needed. It's not for those with severe heart issues, trouble swallowing, prior BCL2 inhibitor therapy, certain genetic abnormalities in their leukemia, active infections like HIV or hepatitis B/C, or a very high white blood cell count.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Venetoclax combined with chemotherapy drugs (fludarabine, cytarabine, filgrastim and idarubicin) on AML patients. The goal is to find the best dose that works well together while monitoring side effects. This combination may be more effective than current treatments by blocking enzymes cancer cells need to grow.See study design
What are the potential side effects?
Venetoclax and these chemotherapy drugs might cause fatigue; nausea; hair loss; increased risk of infection due to low blood cell counts; mouth sores; diarrhea; liver problems signaled by yellowing skin/eyes; easy bruising/bleeding from low platelets. Some side effects could be serious.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML has not improved with standard treatments.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-tumor activity
CR/CRi rate
Drug exposure levels
+7 moreSecondary outcome measures
Morphologic leukemia-free state
Other outcome measures
Exploratory biomarkers
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Dermatitis
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Blood creatinine increased
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 (venetoclax, FLAG-IDA)Experimental Treatment6 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Pegfilgrastim
FDA approved
Venetoclax
FDA approved
Filgrastim
FDA approved
Fludarabine
FDA approved
Idarubicin
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,360 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,671 Previous Clinical Trials
40,926,653 Total Patients Enrolled
Courtney DiNardoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
593 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects my ability to swallow or absorb pills.My leukemia is of a specific type known as acute promyelocytic leukemia.I have previously received BCL2 inhibitor therapy.I have severe heart failure or my heart pumps less than 40% of the blood.My white blood cell count is above 25,000, even if I used hydroxyurea.I am not pregnant, using reliable birth control, or not of childbearing age.I have had a heart attack in the last 6 months or have uncontrolled heart problems.I have HIV or active hepatitis B or C.I am over 65 and considered fit for intensive chemotherapy.My liver enzymes are within normal limits, or high due to leukemia.I agree to avoid unprotected sex and not donate sperm for 90 days after my last dose.My AML has not improved with standard treatments.I can take care of myself and am up and about more than half of my waking hours.I have been diagnosed with AML or high-risk MDS according to WHO criteria.My acute myeloid leukemia (AML) has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, FLAG-IDA)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
What are the primary diseases that Venetoclax has been shown to improve?
"Venetoclax is an effective treatment for radiation syndrome, bone marrow transplantation, and febrile neutropenia."
Answered by AI
Are there any other published reports of Venetoclax being used in a clinical setting?
"At this time, 898 clinical trials are ongoing that involve Venetoclax with 121 of those in Phase 3. The majority of these trials are located in Toronto, Canada, however, there are a total of 22981 clinical trial sites for Venetoclax around the world."
Answered by AI
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