Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome

Part of paid clinical trials in Los Angeles, California.

Sponsor
Brian Jonas
Study ID
NCT02553941
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Given intravenous or subcutaneous
  • Ibrutinib — DRUG
    Given by mouth once daily

Study Details

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.

Key Dates

Start date
May 17, 2016
Status verified
Oct 2022
Primary completion
May 25, 2019
Completion
Nov 7, 2019

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: azacitidine, ibrutinib
    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.

Primary Outcome Measure

Incidence of toxicity of ibrutinib and azacitidine, graded according to the Common Terminology Criteria for Adverse Events [ Time Frame: Within 30 days following the last dose of study drug or the first date starting new anticancer therapy ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of California San DiegoSan DiegoCalifornia92103-
University of California, San FranciscoSan FranciscoCalifornia94118-

Find similar trials in Los Angeles, CA

By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of California San Diego· San Diego, CAUniversity of California, San Francisco· San Francisco, CA

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