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Venetoclax + Chemotherapy for Acute Lymphoblastic Leukemia
Study Summary
This trial is testing the side effects and best dose of Venetoclax in combination with low-intensity chemotherapy in patients with B- or T-cell acute lymphoblastic leukemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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Who is running the clinical trial?
Media Library
- I have a serious infection that isn't getting better with antibiotics.I have leukemia that is either Philadelphia chromosome-positive ALL or Burkitt.I have not taken strong medication that affects liver enzymes within the last week.I do not have severe heart failure.I have been treated with venetoclax before.I am not pregnant or breastfeeding and, if capable of becoming pregnant, will use birth control.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I haven't taken experimental leukemia drugs in the last week, or I've fully recovered from their side effects.I am a woman who can have children and have a recent negative pregnancy test.My leukemia has returned or didn't respond to treatment.I can take care of myself but can't do heavy physical work.I will use effective birth control during and for 4 months after the study.I have a bleeding disorder not related to my cancer.My heart's pumping ability is below 40%.I have hepatitis B, C, or HIV.I do not have another cancer that is expected to shorten my life to under a year.
- Group 1: Experimental (venetoclax, vincristine, cyclophosphamide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any other existing research projects that investigate Venetoclax?
"There are 2265 clinical trials currently underway for Venetoclax. Of these, 481 have reached Phase 3. 70387 different locations worldwide are running studies on this treatment, with a notable concentration in Changsha, Hunan."
What is the usual purpose of Venetoclax?
"Venetoclax is most often used for the treatment of macular edema. It can also be used to treat conditions such as pheochromocytomas, eye, and ulcerative colitis."
Are there any vacancies in this clinical trial for new patients?
"The latest information from clinicaltrials.gov suggests that this study is still looking for more participants. The original posting date was April 3rd, 2019 but the listing has been updated as recently as November 2nd, 2022."
What aims does this experiment hope to achieve?
"The primary outcome of this study, which will be assessed over a Up to 28 days time frame is to Maximum tolerated dose (MTD) (Phase I). Secondary outcomes include Overall response rate (Phase II) which is defined as Will be defined as the percentage of patients achieving a complete response (CR) or CR with inadequate count recovery (CRi). Will estimate the overall response (OR) for the combination treatment, along with the 95% credible interval., Event-free survival (EFS) which is defined as The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher"
How many research participants will be taking part in this investigation?
"That is accurate. The clinicaltrials.gov website has information revealing that this study, which was originally posted on April 3rd 2019, is still recruiting participants. They are looking for 50 individuals from 1 site."
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