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Nucleoside Analog

azacitidine, ibrutinib for Chronic Myelomonocytic Leukemia

Phase 1
Waitlist Available
Research Sponsored by Brian Jonas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed diagnosis of myelodysplastic syndrome
Revised international prognostic scoring system (IPSS-R) intermediate, high or very high
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of first study drug administration until the date of death from any cause, assessed up to 6 months post-treatment
Awards & highlights

Study Summary

This phase Ib trial studies the side effects and best dose of ibrutinib when given together with azacitidine in treating patients with myelodysplastic syndrome that is likely to occur or spread (higher risk) and who were previously treated or untreated and unfit for or refused intense therapy. Ibrutinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes (MDS)
  • Anemia With Excess Blasts

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of first study drug administration until the date of death from any cause, assessed up to 6 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of first study drug administration until the date of death from any cause, assessed up to 6 months post-treatment 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 toxicity of ibrutinib and azacitidine, graded according to the Common Terminology Criteria for Adverse Events
Secondary outcome measures
Disease Free Survival
Muscular Dystrophy
HNR, defined as the proportion of treated subjects who achieve a CR, PR or HI as best response as assessed by the investigator and as defined by the modified IWG 2006 response criteria for MDS
+2 more
Other outcome measures
Change in biomarker levels including BTK, phosphatidylinositol 3 kinase, cluster of differentiation 34, mitogen-activated protein kinase, nuclear transcription factor kappa-B, interleukin 2-inducible T-cell kinase, and peripheral T cells and subsets
Quality of LIfe of the combination of ibrutinib and azacitidine, assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires

Trial Design

1Treatment groups
Experimental Treatment
Group I: azacitidine, ibrutinibExperimental Treatment2 Interventions
Patients receive azacitidine intravenous infusion over 10-40 minutes or subcutaneous on days 1-7 or 1-5 and 8-9, and ibrutinib by mouth one daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Brian JonasLead Sponsor
4 Previous Clinical Trials
69 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,799 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025