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Navitoclax + Ruxolitinib for Myelofibrosis (TRANSFORM-2 Trial)
TRANSFORM-2 Trial Summary
This trial is investigating whether the combination of navitoclax and ruxolitinib is safe and effective in participants with myelofibrosis. Participants will be assigned to either Arm A or Arm B. Arm A will receive navitoclax and ruxolitinib, while Arm B will receive the best available therapy.
TRANSFORM-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRANSFORM-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRANSFORM-2 Trial Design
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- My spleen has grown and can be felt at least 5 cm below my left rib cage since starting ruxolitinib.My myelofibrosis is classified as intermediate-2 or high-risk.I can take care of myself and am up and about more than half of my waking hours.I have been diagnosed with a type of myelofibrosis according to WHO, with significant bone marrow scarring.I have previously been treated with specific cancer drugs or had a stem cell transplant.I am not on blood thinners, except for low dose aspirin or LMWH.My spleen has grown significantly since starting my current treatment.My spleen has grown by 25% or more since starting ruxolitinib.My spleen is enlarged, measuring over 5 cm below my ribcage or has a volume of more than 450 cm3 on a scan.I have been treated with ruxolitinib for my condition.I've completed my current cancer treatment at least a week ago, or it's been 30 days, whichever is shorter.My spleen has grown significantly since starting my treatment.I've been on ruxolitinib for less than 6 months and my disease has worsened.I have symptoms scoring 3 or more on average, or a total score of 12 or more on the MFSAF v4.0.I am eligible for a stem cell transplant.I took ruxolitinib for 6 months or more but stopped because it didn't reduce my spleen size or symptoms got worse after initially improving.I've taken ruxolitinib (at least 10 mg twice daily) for over 28 days but had to stop because I needed more blood transfusions.I can tolerate ruxolitinib doses of 10 mg or more without severe side effects.
- Group 1: Arm B: Best Available Therapy (BAT)
- Group 2: Arm A: Navitoclax + Ruxolitinib
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many people are taking part in this experiment?
"The sponsor, AbbVie, needs to recruit 330 eligible patients from various clinical trial sites. Two locations where this research is taking place include MetroHealth Medical Center in Cleveland, Ohio (ID# 222650) and McGill University Health Center Research Institute in Montreal, Quebec (ID# 222614)."
Are there any other hospitals in this city conducting this experiment?
"Currently, this research is being conducted in 47 centres, which are situated in Cleveland, Montreal, Springdale and many other places. If you enroll as a participant, it would be ideal to choose a location close to you to avoid extensive travel."
Are patients still being recruited for this experiment?
"That is accurate, the clinicaltrials.gov website says that this study is looking for more participants. This research was originally posted on August 31st 2020 and updated as recently as October 3rd 2020. In total, 47 different sites are being used to find the 330 individuals needed for this trial."
What are Navitoclax's primary therapeutic applications?
"Polycythemia vera is a condition that can be managed through the use of Navitoclax. Additionally, this medication helps patients who are resistant or intolerant to hydroxyurea and those with primary myelofibrosis."
What other medical studies have featured Navitoclax as a central treatment?
"Navitoclax was first trialled in 2002 at National Institutes of Health Clinical Center. As of right now, there have been a total 111 completed trials with 106 still active. The majority of these ongoing studies are based out of Cleveland, Ohio."
What are the potential dangers of Navitoclax for patients?
"Navitoclax has received a 3 for safety from our analysts at Power. This is due to the fact that Navitoclax is in Phase 3 clinical trials, meaning that there are data supporting both its efficacy and safety."
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What portion of applicants met pre-screening criteria?
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