Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT03359460
Phase
PHASE1
Status
Completed

Conditions

  • Myelodysplastic Syndrome
  • Previously Treated Myelodysplastic Syndrome
  • Refractory High Risk Myelodysplastic Syndrome
  • Secondary Myelodysplastic Syndrome
  • Therapy-Related Myelodysplastic Syndrome

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Lenalidomide — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of ibrutinib when giving together with lenalidomide in treating patients with myelodysplastic syndrome. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and lenalidomide may work better in treating patients with myelodysplastic syndrome.

Key Dates

Start date
Dec 1, 2017
Status verified
May 2025
Primary completion
Aug 29, 2019
Completion
Nov 17, 2019

Study Design

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

Arms

  • Experimental: Treatment (lenalidomide, ibrutinib)
    Patients receive lenalidomide PO QD on days 1-21 and ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-

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University of California Davis Comprehensive Cancer Center· Sacramento, CA

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