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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
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
Be older than 18 years old
Must not have
currently has unresolved toxicities for which study treatment has been interrupted in the core treatment phase
Received blood platelet transfusion within 28 days prior to first dose of study treatment.
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
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of bone marrow disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am experiencing side effects from a previous treatment that haven't resolved.
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I have received a blood platelet transfusion in the last 28 days.
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I haven't taken any experimental drugs for myelofibrosis, except ruxolitinib, recently.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3 Arm 3: Ruxolitinib monotherapyActive Control1 Intervention
Existing stable dose of ruxolitinib as control for Part 3
Group XIV: Part 2 Arm 6: Ruxolitinib monotherapyActive Control1 Intervention
Existing stable dose of ruxolitinib as control for Part 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1170
Siremadlin
2022
Completed Phase 2
~90
Crizanlizumab
2021
Completed Phase 2
~640
Sabatolimab
2020
Completed Phase 3
~580
Rineterkib
2019
Completed Phase 2
~50
NIS793
2019
Completed Phase 3
~680

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,904 Previous Clinical Trials
4,207,970 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 1 Arm 2: Ruxolitinib + Crizanlizumab, Part 2 Arm 3: Ruxolitinib + Sabatolimab, Part 2 Arm 5: Ruxolitinib + NIS793, Part 1 Arm 1: Ruxolitinib + Siremadlin, Part 1 Arm 3: Ruxolitinib + Sabatolimab, Part 2 Arm 2: Ruxolitinib + Crizanlizumab, Part 3 Arm 1: Ruxolitinib + Compound X, Part 2 Arm 1: Ruxolitinib + Siremadlin, Part 3 Arm 2: Ruxolitinib cessation, Part 3 Arm 3: Ruxolitinib monotherapy, Part 1 Arm 4: Ruxolitinib + Rineterkib, Part 2 Arm 6: Ruxolitinib monotherapy, Part 2 Arm 4: Ruxolitinib + Rineterkib, 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
~7 spots leftby Nov 2025
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