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Accelerated Venetoclax Escalation for Chronic Lymphocytic Leukemia (SAVE Trial)
SAVE Trial Summary
This trial is investigating whether an accelerated dose ramp-up of venetoclax is safe for patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
SAVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAVE Trial Timeline
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 • NCT02005471SAVE Trial Design
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- My cancer has spread to my brain or spinal cord.I had a stem cell transplant less than 6 months ago or I am being treated for graft vs. host disease.I am taking Coumadin or another blood thinner.You currently have a problem with drinking too much alcohol.My white blood cell count has rapidly increased recently.I have not taken venetoclax in the last 6 months.I haven't had cancer treatment or surgery in the last 2 weeks, except for certain allowed therapies.I am receiving CD20 antibody therapy as part of my treatment.I am not taking any strong medications or eating foods that affect CYP3A enzyme activity.My blood tests show worsening anemia or low platelets.My CLL has changed into a more aggressive form of cancer.I am taking 20 mg or less of corticosteroids daily.I have had significant weight loss, fatigue, fevers, or night sweats without infection.I am being treated for cancer that may interfere with venetoclax treatment.I can start treatment sooner if my condition worsens, with approval.My white blood cell count is healthy or can be with treatment.I have not been treated or my treatment didn’t work, and I may get venetoclax alone or with another therapy.I cannot swallow pills or have a condition affecting my stomach or intestines that causes poor nutrient absorption or chronic diarrhea.I agree to use effective birth control or abstain from sex during the study.I have stopped my targeted cancer therapy for a specific time before joining.I have not had major surgery in the last 4 weeks.I have a history of HIV, HCV, or HBV.My spleen is very large, growing, or causing symptoms.I am 18 years old or older.I do not have serious heart problems or recent heart attacks.I have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma and need treatment.My blood condition doesn't improve with standard treatments.I can take care of myself but might not be able to do heavy physical work.My liver is working well.My kidney function is within the required range.I do not have any active infections requiring IV antibiotics.I am on preventive antibiotics with no active infection and my medication is not prohibited.My kidney function is normal.My lymph nodes are very large, growing, or causing symptoms.
- Group 1: Venetoclax
- 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
To what extent is Venetoclax a reliable treatment option for patients?
"Minimal safety and efficacy data is available for Venetoclax, so it was granted a score of 1."
For what illnesses has Venetoclax been proven to be an effective remedy?
"Venetoclax is therapeutically efficacious at treating diffuse large b-cell lymphoma (dlbcl) and various other illnesses, like b-cell lymphomas, polyangium and pemphigus vulgaris."
Are there still opportunities to join this investigation?
"Affirmative, according to clinicaltrials.gov the medical trial is still actively recruiting participants. This study was initially posted on April 14th 2021 with its most recent update appearing June 1st 2022. 40 individuals need be found from a single location to participate in this experiment."
Could you provide a rough estimate of the number of participants in this trial?
"Affirmative. The data hosted on clinicaltrials.gov indicates that this medical trial began accepting applicants since April 14th 2021, and was recently updated June 1st 2022. It is currently recruiting 40 patients from a single location."
Could you elaborate on the prior research conducted concerning Venetoclax?
"At present, 652 studies of Venetoclax are underway with 123 in the third phase. While many trials are based in Edmonton, Alberta, there is a total of 21995 medical sites worldwide conducting research on this drug."
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