Your session is about to expire
← Back to Search
Bcl-2 Inhibitor
Navitoclax + Ruxolitinib for Myelofibrosis (TRANSFORM-1 Trial)
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan
Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights
TRANSFORM-1 Trial Summary
This trial is investigating whether a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.
Who is the study for?
Adults with myelofibrosis, a bone marrow cancer causing anemia and enlarged spleen. Participants must have certain levels of disease severity and symptoms, be able to complete symptom assessments, and not be eligible for stem cell transplantation due to various reasons.Check my eligibility
What is being tested?
The trial is testing if taking Navitoclax tablets along with Ruxolitinib is better than just Ruxolitinib for reducing spleen size in myelofibrosis patients. It's a global study involving around 230 participants who will receive treatments orally.See study design
What are the potential side effects?
Potential side effects may include issues related to blood cells such as anemia or increased bleeding risk due to low platelets, fatigue from the treatment burden, and other possible drug-related reactions that will be monitored through regular medical checks.
TRANSFORM-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spleen is enlarged, confirmed by a scan.
Select...
My myelofibrosis is classified as intermediate-2 or high-risk.
Select...
I have severe symptoms of my condition, scoring 3 or more on at least two.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with Primary MyeloFibrosis or Secondary MyeloFibrosis.
TRANSFORM-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
Secondary outcome measures
Change In Fatigue
Change in Physical Functioning
Change in Total Symptom Score (TSS)
+6 moreTRANSFORM-1 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Navitoclax + RuxolitinibExperimental Treatment2 Interventions
Participants will receive Navitoclax in combination with Ruxolitinib
Group II: Placebo for Navitoclax + RuxolitinibActive Control2 Interventions
Participants will receive placebo for Navitoclax and Ruxolitinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navitoclax
2012
Completed Phase 2
~90
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
500,853 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,687 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spleen is enlarged, confirmed by a scan.My myelofibrosis is classified as intermediate-2 or high-risk.I have severe symptoms of my condition, scoring 3 or more on at least two.I am not on blood thinners, except for low dose aspirin or LMWH.I have previously been treated with specific cancer drugs or had a stem cell transplant.I cannot have a stem cell transplant due to my age, health conditions, or lack of a matching donor.I can take care of myself and am up and about more than half of my waking hours.I have been treated with a JAK-2 inhibitor before.I have been diagnosed with Primary MyeloFibrosis or Secondary MyeloFibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Navitoclax + Ruxolitinib
- Group 2: Placebo for Navitoclax + Ruxolitinib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most popular reason people are prescribed Navitoclax?
"Navitoclax is most frequently used to treat polycythemia vera, but it can also help patients with primary myelofibrosis who are either resistant or intolerant to hydroxyurea."
Answered by AI
What is the latest word on Navitoclax's FDA approval process?
"Navitoclax received a score of 3 on Power's safety scale. This is due to the fact that it is a Phase 3 trial, signifying that there is both efficacy data as well as multiple rounds of safety data."
Answered by AI
Is this research program currently enrolling new participants?
"That is correct. The clinical trial is still open and is looking for 230 patients at 52 locations, according to the information provided on clinicaltrials.gov."
Answered by AI
What other pharmaceutical studies has Navitoclax been used in?
"Navitoclax was first studied in 2002 at the National Institutes of Health Clinical Center. There have been a total of 110 clinical trials completed. Currently, there are 107 live studies, a majority of which are based in Ann Arbor, Michigan."
Answered by AI
In how many different medical hospitals is this clinical trial being conducted?
"Presently, this research is looking for participants from 52 different locations, with Ann Arbor, Barrie and Knoxville being a few of them. If you are interested in enrolling, it would be best to choose a clinic near to your residence to cut down on travel time."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger