Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia
A Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) for Treatment of Relapsed Hairy Cell Leukemia
9 other identifiers
interventional
44
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2013
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
April 26, 2013
CompletedStudy Start
First participant enrolled
April 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
April 13, 2026
March 1, 2026
16.7 years
April 24, 2013
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate (complete response [CR] and partial response [PR])
Calculated as the proportion of patients who achieve a PR or CR to therapy within the first 32 weeks of therapy divided by the total number of evaluable patients.
32 weeks
Secondary Outcomes (9)
Incidence of adverse events
Up to 30 days after treatment
Progression-free survival
From the date of study registration to the date of event or the date of last follow-up if no event has occurred, assessed up to 3 years
Overall survival
From the date of study registration to the date of event or the date of last follow-up if no event has occurred, assessed up to 3 years
Rate of molecular remission (minimal residual disease [MRD]-negative CR)
Up to 32 weeks
Immunologic outcomes during single agent ibrutinib administration
Up to 12 months
- +4 more secondary outcomes
Other Outcomes (1)
Pharmacokinetic (PK) parameters
Predose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on days 1 and 8 of cycle 1 and predose and 2 hours on days 15 and 22 of cycle 1 and day 1 of cycle 2
Study Arms (1)
Treatment (ibrutinib)
EXPERIMENTALPatients 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.
Interventions
Undergo bone marrow aspiration and biopsy
Undergo CT
Given PO
Undergo ultrasound
Undergo blood sample collection
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of hairy cell leukemia or variant according to World Health Organization (WHO) criteria with any of the following indications for therapy:
- Hemoglobin \< 11 g/dL
- Platelet count \< 100,000/mL
- Absolute neutrophil count \< 1,000/mL
- Progressive or symptomatic splenomegaly or hepatomegaly
- Enlarging lymphadenopathy \>= 2 cm
- Absolute lymphocyte count \> 5,000/mL
- Disease related constitutional symptoms consisting of unexplained weight loss exceeding 10% of body weight over the preceding 6 months, Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 fatigue, fevers \> 100.5 degrees Fahrenheit (F) or night sweats for greater than 2 weeks without evidence of infection
- Patients with classic hairy cell leukemia may receive therapy under the following conditions:
- After at least 1 prior purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine), or
- Relapsed or de novo disease if deemed medically unfit for therapy with a purine nucleoside analog
- Because there is no recognized standard of care for patients with variant hairy cell leukemia, both previously treated and previously untreated patients with this diagnosis will be eligible
- Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ibrutinib in patients \< 18 years of age, children are excluded from this study, but may be eligible for future pediatric trials
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy of greater than 12 months
- +7 more criteria
You may not qualify if:
- Chemotherapy =\< 21 days prior to first administration of study treatment and/or monoclonal antibody =\< 6 weeks prior to first administration of study treatment
- Patients who are receiving any other investigational agents
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic composition as ibrutinib
- Ibrutinib is extensively metabolized by CYP3A4/5; patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or patients who require continuous treatment with a strong CYP3A inhibitor; therefore, any medications or substances that are strong inhibitors of CYP3A4/5 should be discontinued; patients unable to change these medications must be excluded from participation; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; recent infections requiring systemic treatment need to have completed therapy \> 14 days before the first dose of study drug
- Pregnant women are excluded from this study because ibrutinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ibrutinib, breastfeeding should be discontinued if the mother is treated with ibrutinib
- Human immunodeficiency virus (HIV)-positive patients will be eligible unless they have been previously diagnosed with an acquired immune deficiency syndrome (AIDS)-defining illness
- Patients who require anticoagulation with warfarin (Coumadin) or who have taken warfarin within 28 days prior to enrollment are not eligible due to a potential increased risk of hemorrhage; patients who are currently taking vitamin K antagonists are also ineligible for this study
- Patients requiring daily corticosteroids at a prednisone equivalent of \>= 20 mg daily should not be enrolled; if corticosteroids can be discontinued (or reduced to \< 20 mg per day of prednisone or equivalent), the discontinuation or dose reduction should be done at least 7 days prior to first dose
- Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor
- Major surgery within 4 weeks of first dose of study drug
- A history of prior malignancy, with the exception of the following:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening, and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Rogers KA, Andritsos LA, Wei L, McLaughlin EM, Ruppert AS, Anghelina M, Blachly JS, Call T, Chihara D, Dauki A, Guo L, Ivy SP, James LR, Jones D, Kreitman RJ, Lozanski G, Lucas DM, Ngankeu A, Phelps M, Ravandi F, Schiffer CA, Carson WE, Jones JA, Grever MR. Phase 2 study of ibrutinib in classic and variant hairy cell leukemia. Blood. 2021 Jun 24;137(25):3473-3483. doi: 10.1182/blood.2020009688.
PMID: 33754642DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerry A Rogers
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
April 26, 2013
Study Start
April 30, 2013
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
April 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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