44 Participants Needed

Ibrutinib for Hairy Cell Leukemia

Recruiting at 4 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any strong CYP3A4/5 inhibitors at least 7 days before starting ibrutinib. If you are on warfarin or require daily corticosteroids at a high dose, you may need to stop or adjust these medications as well. It's important to discuss your current medications with the study team to ensure they don't interfere with the trial.

Is ibrutinib safe for humans?

Ibrutinib has been studied in various conditions and is generally considered safe, but it can cause side effects like diarrhea, fatigue, muscle pain, and nausea. Serious risks include bleeding, heart problems, and infections, so patients should be monitored closely.12345

How is the drug ibrutinib unique in treating hairy cell leukemia?

Ibrutinib is unique because it is an oral medication that targets a specific protein called Bruton's tyrosine kinase, which is involved in the growth of cancerous B-cells. This makes it different from traditional chemotherapy, as it specifically disrupts cancer cell signaling, offering a novel approach for patients who do not respond well to standard treatments.15678

What data supports the effectiveness of the drug Ibrutinib for treating Hairy Cell Leukemia?

In a study, Ibrutinib showed a 54% best overall response rate in patients with relapsed or variant hairy cell leukemia, and 73% of patients had no disease progression after 36 months, suggesting it may help control the disease.134910

Who Is on the Research Team?

KA

Kerry A Rogers

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with relapsed Hairy Cell Leukemia who've had prior treatment. They should have certain blood count levels, be fit enough for daily activities (ECOG <=2), and not be pregnant or breastfeeding. Contraception is required during the study. Exclusions include uncontrolled illnesses, recent major surgery, other cancers within 3 years (some exceptions apply), known allergies to similar drugs, active hepatitis B/C infection, strong CYP3A inhibitors use recently, and certain cardiovascular diseases.

Inclusion Criteria

Agreement to use adequate contraception for women of child-bearing potential and men
Specific laboratory criteria including creatinine, bilirubin, AST, PT/INR, PTT, and baseline peripheral blood cell counts
I have been diagnosed with hairy cell leukemia that needs treatment.
See 4 more

Exclusion Criteria

Pregnant or breastfeeding women
Incarceration at the time of enrollment
I have lingering side effects from previous cancer treatments.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ibrutinib orally once daily on days 1-28. Cycles repeat every 28 days for up to 8 cycles if lack of response, up to 12 cycles if failure to achieve an objective response, or continually at physician discretion.

32 weeks
Regular visits for bone marrow aspiration, biopsy, blood sample collection, and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 3 years
Follow-up every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ibrutinib
Trial Overview The trial tests Ibrutinib's effectiveness in patients whose Hairy Cell Leukemia has returned after initial improvement. It explores whether Ibrutinib can halt cancer cell growth by inhibiting enzymes necessary for their proliferation.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment6 Interventions
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.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
  • Graft-versus-host disease
🇺🇸
Approved in United States as Imbruvica for:
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
  • Graft-versus-host disease
🇨🇦
Approved in Canada as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
🇯🇵
Approved in Japan as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Hairy cell leukemia (HCL) is effectively treated with purine analogs, but about half of patients relapse and may become resistant to these treatments, necessitating alternative therapies.
Targeting the BRAF-V600E mutation with specific inhibitors like vemurafenib or dabrafenib offers a promising chemotherapy-free strategy, especially for patients at risk of severe infections or those with relapsed HCL, and can be combined with rituximab for enhanced efficacy.
How I treat refractory/relapsed hairy cell leukemia with BRAF inhibitors.Falini, B., De Carolis, L., Tiacci, E.[2022]
Ibrutinib is a targeted therapy specifically designed for treating chronic lymphocytic leukemia (CLL), which is a type of cancer that affects the blood and bone marrow.
This novel treatment works by inhibiting Bruton's tyrosine kinase (BTK), a key enzyme that helps cancer cells survive and proliferate, leading to improved patient outcomes.
Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia.Parmar, S., Patel, K., Pinilla-Ibarz, J.[2021]
Ibrutinib (Imbruvica) is now approved for treating graft-versus-host disease in pediatric patients aged one year and older who have not responded to other systemic therapies, highlighting its efficacy in a challenging patient population.
The treatment carries significant risks, including severe side effects like hemorrhage, infections, and cardiac issues, necessitating careful monitoring and education for patients and caregivers about these potential adverse effects.
Drug Receives New Indication for Pediatric Graft-Versus-Host Disease.Aschenbrenner, DS.[2023]

Citations

Phase 2 study of ibrutinib in classic and variant hairy cell leukemia. [2023]
How I treat refractory/relapsed hairy cell leukemia with BRAF inhibitors. [2022]
Variant form of hairy cell leukemia. [2023]
Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia. [2021]
Hairy cell leukemia: treatment prospects. [2007]
Drug Receives New Indication for Pediatric Graft-Versus-Host Disease. [2023]
Ibrutinib: A Review in Chronic Lymphocytic Leukaemia. [2021]
Ibrutinib: first global approval. [2022]
Pharmaceutical approval update. [2021]
Ibrutinib: a review of its use in patients with mantle cell lymphoma or chronic lymphocytic leukaemia. [2022]
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