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Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome

NCT02553941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-10-06

No results posted yet for this 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.

Conditions

  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndrome
  • Previously Treated Myelodysplastic Syndrome
  • Refractory Anemia With Excess Blasts in Transformation
  • Secondary Myelodysplastic Syndrome

Interventions

DRUG

Azacitidine

Given intravenous or subcutaneous

DRUG

Ibrutinib

Given by mouth once daily

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Brian Jonas

    lead OTHER

Principal Investigators

  • Brian Jonas · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-17
Primary Completion
2019-05-25
Completion
2019-11-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02553941 on ClinicalTrials.gov