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Leukemia, OtherHCL-PDRNCT02560883

Hairy Cell Leukemia Patient Data Registry

An observational study of Leukemia, Other, run by Ohio State University Comprehensive Cancer Center at 8 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Other
How many people
5,000 participants
Where
8 sitesin 3 countries
Study dates
2 Jan 2013to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will be a multi-institutional, international project that will collate clinical information from patients with Hairy Cell Leukemia from participating institutions in the Hairy Cell Leukemia Foundation. Patients within the United States with HCL, who live in remote areas, without access to a HCLFCenter of Excellence, may voluntarily submit their name and contact information, through the Hairy Cell Leukemia Foundation website.

Who may be able to join

  • Patients with classic hairy cell leukemia
  • Patients with the variant of hairy cell leukemia.

Who cannot join

  • Children are excluded from the study, since Hairy Cell Leukemia wasn't described in children.

Trial locations and contacts

8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Hairy Cell Leukemia Research Data Registry contact

614-685-4296

HCLRegistry@osumc.edu

Elena Botoulas, BS contact

614-685-0635

8 sites in 3 countries

United States5 sites, 5 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Derick Campbell, 614-366-5196, HCLRegistry@osumc.edu

    Michael Grever, MD

    Recruiting

  • University of Miami/Soffer Clinical Research Center

    Miami, Florida, 33136

    Peggy Gonzalez, M.S.Ed., 305-243-8091, pgonzalez@med.miami.edu

    Justin Taylor, M.D.

    Recruiting

  • Mount Sinai Medical Center of Florida

    Miami Beach, Florida, 33140

    Carla Romagnoli, MD, 305-674-2121 ext. 50362, carla.romagnoli@msmc.com

    614-685-0635, HCLRegistry@osumc.edu

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Matthew Holets, 507-266-7208, holets.matthew@mayo.edu

    Sameer Parikh, MD

    Recruiting

  • University of Rochester /Wilmot Cancer Institute

    Rochester, New York, 14642

    Tina Faugh, AAS, 585-273-3258, tina_faugh@urmc.rochester.edu

    Clive Zent, MD

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • BC Cancer, Part of the Provincial Health Services Authority

    Vancouver, Britsh Columbia, V5Z 4E6

    Steven Huang, 604-877-6000 ext. 2017, steven.huang@bccancer.bc.ca

    Recruiting

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Sarah Dentry, PhD, 2048042983, sdentry@cancercare.mb.ca

    Banerji Banerji, MD

    Recruiting

Other trials in Canada

Australia1 site, 1 recruiting

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, VIC 3000

    Jessica Klass, 8559 7266, Jessica.Klass@mh.org.au

    Philip Thompson, MBBS

    Recruiting

Other trials in Australia

About this study

Official title: Clinical Research in Hairy Cell Leukemia: Surveillance and Documentation of Clinical Outcomes in a Rare Form of Adult Leukemia

The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 1,000 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends in outcomes, recognize the most effective treatments, discover previously unknown complications of the disease, and design clinical trials for new therapies.

Read the detailed description

This clinical registry is being established to collect de-identified information on this rare disease. The registry created by assimilation of de- identified coded patient data will centralize information that can be used to improve the management of the many complications of this disease and its treatment. This study is focused on collection of clinically and biologically meaningful endpoints across multiple institutions; as such, it is not focused on a specific set of hypotheses but will collect data that will facilitate such analyses. The investigators will collect information related to the symptoms and the clinical course of the disease, to the complications from the disease and its treatment, presence of minimal residual disease, frequency of relapse and subsequent management, data on novel molecular markers associated with the prognosis.

In conjunction with the Department of Bioinformatics at The Ohio State University, the investigators have created a system for safeguarding the confidentiality and the identity of all patients who agree to participate in this research registry. Each participating institution will be responsible for de-identification of the data, using software developed by The Ohio State University, Department of Biomedical Informatics, before it is used in the registry. Each institution will confidentially maintain a code for linking this information to an individual patient.

Each participating institution will have direct control over the data contained in the registry that is associated with their respective patient population. As a result of these measures, should a patient wish to withdraw from the registry, the responsible institution will be able to immediately remove all records related to that patient from the registry.

Conditions
Leukemia, Other
Keywords
Hairy Cell
Medical subject headings
Leukemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surveillance

    Establish a database of Hairy Cell Leukemia patients diagnosed or living in US to track Hairy Cell Leukemia disease course, patient reported outcomes, morbidity, and patient survival.

    Measured: up to 25 years

Secondary outcomes (1)

  1. Research

    facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. Assess the number and type of infections recorded in patients following diagnosis and before therapy versus the infectious complications following administration of therapy for the disease. Identify and characterize patients at each participating institution with autoimmune complications associated with their diagnosis (e.g., polyarticular arthritis; immune cytopenias; vasculitis), and describe the response to immunosuppressive therapy. Collect data regarding treatment for hairy cell leukemia and its impact on the autoimmune complications of the disease.

    Measured: up to 25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2015 (estimated)
  2. Study start2 Jan 2013
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560883
Sponsor's protocol ID
OSU-12194
Acronym
HCL-PDR
Status last verified
Jun 2026
First submitted
20 Aug 2015
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, Other, run by Ohio State University Comprehensive Cancer Center at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hairy Cell Leukemia Research Data Registry (614-685-4296, HCLRegistry@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surveillance (time frame: up to 25 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02560883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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