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Navitoclax + Ruxolitinib for Myelofibrosis (TRANSFORM-2 Trial)

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
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 last visit up to 5 years
Awards & highlights

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.

Who is the study for?
Adults with relapsed or refractory Myelofibrosis, a type of blood cancer that causes bone marrow scarring and spleen enlargement. Participants must have specific symptoms and spleen size criteria, be classified as intermediate-2 or high-risk by DIPSS+, and have been treated with ruxolitinib previously but not responded well.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of an oral Navitoclax tablet in combination with Ruxolitinib versus Best Available Therapy (BAT) for reducing spleen volume in Myelofibrosis patients. It's a randomized study where neither participants nor doctors choose the treatment group.See study design
What are the potential side effects?
Potential side effects may include digestive issues, changes in blood counts, fatigue, potential risk of infection due to immune system impact, liver function changes, bleeding complications, and other drug-specific reactions.

TRANSFORM-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My spleen has grown and can be felt at least 5 cm below my left rib cage since starting ruxolitinib.
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My myelofibrosis is classified as intermediate-2 or high-risk.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with a type of myelofibrosis according to WHO, with significant bone marrow scarring.
Select...
I've been on ruxolitinib for less than 6 months and my disease has worsened.
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I have symptoms scoring 3 or more on average, or a total score of 12 or more on the MFSAF v4.0.
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My spleen has grown significantly since starting my current treatment.
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My spleen has grown by 25% or more since starting ruxolitinib.
Select...
My spleen is enlarged, measuring over 5 cm below my ribcage or has a volume of more than 450 cm3 on a scan.
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I have been treated with ruxolitinib for my condition.
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My spleen has grown significantly since starting my treatment.
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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.
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I've taken ruxolitinib (at least 10 mg twice daily) for over 28 days but had to stop because I needed more blood transfusions.
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I can tolerate ruxolitinib doses of 10 mg or more without severe side effects.

TRANSFORM-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last visit up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and last visit up to 5 years for reporting.

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
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time
Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)
Anemia
+6 more

TRANSFORM-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Navitoclax + RuxolitinibExperimental Treatment2 Interventions
Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
Group II: Arm B: Best Available Therapy (BAT)Active Control1 Intervention
Participants will receive one of the BAT options, per the investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Navitoclax
2012
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
950 Previous Clinical Trials
496,598 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
390 Previous Clinical Trials
141,389 Total Patients Enrolled

Media Library

Best Available Therapy (BAT) Clinical Trial Eligibility Overview. Trial Name: NCT04468984 — Phase 3
Myelofibrosis Research Study Groups: Arm B: Best Available Therapy (BAT), Arm A: Navitoclax + Ruxolitinib
Myelofibrosis Clinical Trial 2023: Best Available Therapy (BAT) Highlights & Side Effects. Trial Name: NCT04468984 — Phase 3
Best Available Therapy (BAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468984 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
What portion of applicants met pre-screening criteria?
Met criteria
~28 spots leftby Aug 2024