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Ruxolitinib + Stem Cell Transplant for Acute Myeloid Leukemia
Study Summary
This trial is studying ruxolitinib to see how well it works in preventing relapse in people with acute myeloid leukemia who have undergone allogeneic stem cell transplantation.
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 2020 Phase 3 trial • 149 Patients • NCT02038036Trial Design
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- My organ functions are within normal ranges.I have a history of heart failure or known heart problems.My AML is in the first complete remission.I am between 60 and 80 years old.I can take care of myself and am up and about more than half of the day.I agree to use contraception during and after the study.I am set to receive a specific type of stem cell transplant from a donor.I am on medication for a long-term or active infection.I am planning to undergo a treatment that reduces T-cells.My MDS diagnosis is confirmed through lab tests.I have had serious heart rhythm problems.I am HIV-positive.I currently have an infection that isn't under control.I have had cancer before, but it meets the trial's specific conditions.I have had a stem cell transplant from a donor.I am currently on IV antibiotics for an infection.I do not have any uncontrolled illnesses.
- Group 1: Ruxolitinib
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 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.
- 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
Does this experiment have an age limit?
"The target recruitment pool for this trial are patients that fall in the age range of 60 to 80 years old."
How many people can join this experiment at most?
"That is correct. The information available on clinicaltrials.gov confirms that the study is still recruiting participants. This particular trial was posted on November 3rd, 2017 and was last updated October 21st, 2020. They are looking for a total of 64 individuals who will be spread out among 6 different locations."
Does Ruxolitinib have any potentially harmful side effects?
"While there is some clinical data supporting the safety of Ruxolitinib, as this is a Phase 2 trial, there is currently no evidence to suggest that it is an effective medication."
Is this study currently looking for participants?
"This clinical trial is actively recruiting participants, as indicated on the clinicaltrials.gov website. The trial was first posted on November 3, 2017 and was last updated on October 21, 2020."
Can you tell me some of the most common reasons why patients are prescribed Ruxolitinib?
"Ruxolitinib is frequently prescribed to patients with polycythemia vera. However, it can also be an effective treatment for hydroxyurea-resistant or intolerant polycythemia and primary myelofibrosis."
Is this study taking place across a broad geographical area in the US?
"Beth Israel Deaconess Medical Center in Boston, Washington University in Saint Louis, and the Medical College of Wisconsin are a few notable locations conducting this clinical trial. 6 other research sites are also participating."
What do we already know about Ruxolitinib from other research?
"Ruxolitinib was first studied in the year 2002 at National Institutes of Health Clinical Center, 9000 Rockville Pike. 92 clinical trials have been completed since then. Right now, there are 99 ongoing studies with a large number taking place in Boston, Massachusetts."
How can I sign up to be a part of this clinical trial?
"This trial is for patients aged 60 to 80 with leukemia or myeloid. To be eligible, the following must apply: No extramedullary leukemia, GVHD prophylaxis is comprised of tacrolimus / short course methotrexate as defined by tacrolimus started prior to day 0 of HCT and methotrexate given after HCT on days +1, +3 and +6 ± +11 at a dose of 5-10 mg/m2 IV. Exact logistics are at the discretion of the treating institution., Donors must be 8/8 HLA-matched ("
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