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Janus Kinase (JAK) Inhibitor

Ruxolitinib Combos for Myelofibrosis (ADORE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have been treated with ruxolitinib for at least 12 weeks prior to first dose of study treatment
Subjects have diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-essential thrombocythemia (ET) (PET-MF) or post-polycythemia vera (PV) myelofibrosis (PPV-MF) according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) 2007 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to disease progression, which is up to 24 weeks for part 1 or through study completion, an average of 1 year, for part 2 and part 3
Awards & highlights

ADORE Trial Summary

This trial will test the safety and effectiveness of combining ruxolitinib with 5 other drugs to treat myelofibrosis.

Who is the study for?
This trial is for individuals with primary myelofibrosis or those who developed it after essential thrombocythemia or polycythemia vera. Participants must have been on a stable dose of ruxolitinib for at least 4 weeks and show clinical benefits from the treatment. They should not have had splenic irradiation recently, blood transfusions within the last month, severe allergies to biologics, or high levels of blasts in their blood.Check my eligibility
What is being tested?
The study tests how safe and effective it is to combine ruxolitinib with five other drugs: siremadlin, crizanlizumab, sabatolimab, rineterkib, and NIS793 in treating myelofibrosis. It aims to understand the combined treatments' effects on the disease's progression and symptoms.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills during drug administration, fatigue, digestive issues including nausea or diarrhea, increased risk of infections due to immune suppression.

ADORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with ruxolitinib for at least 12 weeks.
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I have been diagnosed with a specific type of bone marrow disorder.
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My treatment has shown benefits as assessed by my doctor.
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I have been on a stable dose of ruxolitinib for at least 4 weeks.
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My spleen is enlarged, either felt below my ribs or confirmed by a scan.

ADORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to disease progression, which is up to 24 weeks for part 1 or through study completion, an average of 1 year, for part 2 and part 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to disease progression, which is up to 24 weeks for part 1 or through study completion, an average of 1 year, for part 2 and part 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities within the first 2 cycles
Response rate at the end of cycle 6 or cycle 8
Secondary outcome measures
Area under the Plasma Concentration versus Time Curve (AUC)
Change in spleen length from baseline
Change in spleen volume from baseline
+11 more

ADORE Trial Design

14Treatment groups
Experimental Treatment
Active Control
Group I: Part 3 Arm 2: Ruxolitinib cessationExperimental Treatment1 Intervention
Compound from Part 2 added to existing stable dose of ruxolitinib for 3 cycles followed by compound monotherapy
Group II: Part 3 Arm 1: Ruxolitinib + Compound XExperimental Treatment1 Intervention
Compound from Part 2 (to be confirmed) added to existing stable dose of ruxolitinib
Group III: Part 2 Arm 5: Ruxolitinib + NIS793Experimental Treatment2 Interventions
NIS793 added to existing stable dose of ruxolitinib
Group IV: Part 2 Arm 4: Ruxolitinib + RineterkibExperimental Treatment2 Interventions
Rineterkib added to existing stable dose of ruxolitinib
Group V: Part 2 Arm 3: Ruxolitinib + SabatolimabExperimental Treatment2 Interventions
Sabatolimab added to existing stable dose of ruxolitinib
Group VI: Part 2 Arm 2: Ruxolitinib + CrizanlizumabExperimental Treatment2 Interventions
Crizanlizumab added to existing stable dose of ruxolitinib
Group VII: Part 2 Arm 1: Ruxolitinib + SiremadlinExperimental Treatment2 Interventions
Siremadlin added to existing stable dose of ruxolitinib
Group VIII: Part 1 Arm 5: Ruxolitinib + NIS793Experimental Treatment2 Interventions
Safety run-in of NIS793 added to existing stable dose of ruxolitinib
Group IX: Part 1 Arm 4: Ruxolitinib + RineterkibExperimental Treatment2 Interventions
Dose escalation of Rineterkib added to existing stable dose of ruxolitinib
Group X: Part 1 Arm 3: Ruxolitinib + SabatolimabExperimental Treatment2 Interventions
Safety run-in of Sabatolimab added to existing stable dose of ruxolitinib
Group XI: Part 1 Arm 2: Ruxolitinib + CrizanlizumabExperimental Treatment2 Interventions
Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
Group XII: Part 1 Arm 1: Ruxolitinib + SiremadlinExperimental Treatment2 Interventions
Dose escalation of siremadlin added to existing stable dose of ruxolitinib
Group XIII: Part 2 Arm 6: Ruxolitinib monotherapyActive Control1 Intervention
Existing stable dose of ruxolitinib as control for Part 2
Group XIV: Part 3 Arm 3: Ruxolitinib monotherapyActive Control1 Intervention
Existing stable dose of ruxolitinib as control for Part 3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siremadlin
2022
Completed Phase 1
~40
NIS793
2017
Completed Phase 1
~120
Ruxolitinib
2018
Completed Phase 3
~1140
Crizanlizumab
2021
Completed Phase 2
~600

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,540 Total Patients Enrolled

Media Library

Ruxolitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04097821 — Phase 1 & 2
Myelofibrosis Research Study Groups: Part 2 Arm 1: Ruxolitinib + Siremadlin, Part 2 Arm 2: Ruxolitinib + Crizanlizumab, Part 2 Arm 3: Ruxolitinib + Sabatolimab, Part 1 Arm 4: Ruxolitinib + Rineterkib, Part 2 Arm 4: Ruxolitinib + Rineterkib, Part 1 Arm 1: Ruxolitinib + Siremadlin, Part 1 Arm 2: Ruxolitinib + Crizanlizumab, Part 1 Arm 3: Ruxolitinib + Sabatolimab, Part 3 Arm 1: Ruxolitinib + Compound X, Part 2 Arm 6: Ruxolitinib monotherapy, Part 3 Arm 2: Ruxolitinib cessation, Part 3 Arm 3: Ruxolitinib monotherapy, Part 2 Arm 5: Ruxolitinib + NIS793, Part 1 Arm 5: Ruxolitinib + NIS793
Myelofibrosis Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT04097821 — Phase 1 & 2
Ruxolitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04097821 — Phase 1 & 2

Frequently Asked Questions

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

Are people still able to sign up for this clinical trial?

"Currently, this study is not taking applications. The posting date was September 26th, 2019 and the most recent edit was November 10th, 2022. However, there are many other trials currently looking for patients with primary myelofibrosis (111) or NIS793 (123)."

Answered by AI

How many test subjects are part of this experiment?

"Unfortunately, this study is not presently looking for new recruits. The trial was initially posted on 9/26/2019 and was most recently edited on 11/10/2022. There are, however, many other studies that might be a better fit. For example, there are 111 clinical trials actively admitting participants with primary myelofibrosis and 123 studies for NIS793 actively looking for participants."

Answered by AI

What is the primary ailment that NIS793 has been shown to improve?

"NIS793 is an effective treatment against polycythemia, primary myelofibrosis, and hydroxyurea resistance or intolerance."

Answered by AI

What are the objectives of this research?

"The primary objective of this clinical trial is to Response rate at the end of cycle 6 or cycle 8, which will be measured over a period of approximately Baseline to the end of Cycle 2 (6 or 8 weeks). Secondary outcomes include Maximum (peak) observed plasma drug concentration (Cmax), Change in symptoms of MFSAF v4.0 from baseline, and Presence and/or concentration of anti-drug antibody."

Answered by AI
~8 spots leftby Mar 2025