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Vemurafenib + Rituximab for Hairy Cell Leukemia
Study Summary
This trial is testing a new, oral drug combination for the treatment of hairy cell leukemia that is hoped to be more effective and have fewer side effects than the current standard-of-care chemotherapy.
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.Trial Design
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- I agree to use barrier contraception if my partner can have children.My liver and kidney functions are within acceptable ranges.I haven't had chemotherapy, rituximab, or BRAF inhibitors recently.My HCL cancer is confirmed to be BRAF V600E positive.I can take care of myself and am up and about more than half of the day.I haven't had cancer, except for certain types treated with the intent to cure, in the last 2 years.I am 18 years old or older.I have not had major surgery in the last 4 weeks.I have either not been treated for my condition, or my initial treatment didn't work, or my condition came back after treatment.I am willing and able to follow the study's schedule and procedures.My blood counts are low enough to start standard treatment.I have HIV, hepatitis B or C, or a significant liver disease history.My hairy cell leukemia does not have the BRAF V600E mutation.
- Group 1: Low dose Vemurafenib and Rituximab
- 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 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
Is it feasible for me to participate in this investigation?
"This scientific experiment is searching for twenty people with leukemia aged 18 to 90. To become eligible, individuals must pass a serum pregnancy test conducted within the week prior to receiving treatment (only applicable for women premenopausal). Additionally, participants have to sign an informed consent document and meet certain medical criteria such as having ECOG performance status of 0-2 ,acceptable organ function during screening not exacerbated by HCL and bilirubin ≤ 1.5 times upper limit of normal etc. Lastly, male patients with female partners are expected to use barrier contraception while all women of childbearing potential need acceptably effective contraceptive methods throughout the study's duration."
Are any new participants being admitted for this trial currently?
"According to clinicaltrials.gov, this medical experiment is currently searching for eligible patients with the trial having been posted on January 1st 2022 and most recently updated on May 19th of that same year."
Has the combination of low dose vemurafenib and rituximab been sanctioned by the U.S Food & Drug Administration?
"Our team at Power has rated the safety of Low dose vemurafenib plus rituximab as a 2. This is due to Phase 2 trial results, providing limited data regarding its efficacy and some information concerning its security."
How many participants are currently partaking in this clinical research?
"Affirmative. It is evident from the information hosted on clinicaltrials.gov that this medical trial first appeared online in January of 2022 and was last updated in May, with an aim to recruit 20 patients at a single site."
Is the age cutoff for participation in this clinical trial under 55 years old?
"To be eligible for this medical trial, patients must have attained the age of majority and not yet reached their ninetieth birthday. There are 427 trials available to those below 18 years old and 1,127 studies accessible to individuals over 65."
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