Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01841723
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Hairy Cell Leukemia
  • Hairy Cell Leukemia Variant
  • Recurrent Hairy Cell Leukemia
  • Recurrent Hairy Cell Leukemia Variant

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Ibrutinib — DRUG
    Given PO
  • Ultrasound Imaging — PROCEDURE
    Undergo ultrasound

Study Details

This phase II trial studies how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Apr 30, 2013
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib)
    Patients receive ibrutinib PO QD on days 1-28. Cycles repeat every 28 days for up to 8 cycles if lack of response to therapy, up to 12 cycles if failure to achieve an objective response (CR/PR), or continually at per physician discretion in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow aspiration and biopsy, blood sample collection, and CT or ultrasound throughout the study.

Primary Outcome Measure

Overall response rate (complete response [CR] and partial response [PR]) [ Time Frame: 32 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Mayo Clinic in RochesterRochesterMinnesota55905-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MDWayne State University/Karmanos Cancer Institute· Detroit, MIMayo Clinic in Rochester· Rochester, MNOhio State University Comprehensive Cancer Center· Columbus, OHM D Anderson Cancer Center· Houston, TX

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