Assessing Medical Trial Experiences of Hairy Cell Leukemia Patients

NCT05859932 | Not Yet Recruiting

• 1 other identifier: 81405664
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The percentages of participants in clinical studies haven't always been perfectly representative of a particular group. This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for hairy cell leukemia. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of hairy cell leukemia studies.

Conditions

Hairy Cell Leukemia

Keywords

hairy cell leukemia

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a hairy cell leukemia clinical study.

  3 months

• Number of hairy cell leukemia study participants who remain in clinical trial until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are actively considering involvement in an observational hairy cell leukemia clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• Aged ≥ 18 years old
• Ability to understand and the willingness to sign a written informed consent document.
• Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

You may not qualify if:

• Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
• Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Chihara D, Arons E, Stetler-Stevenson M, Yuan CM, Wang HW, Zhou H, Raffeld M, Xi L, Steinberg SM, Feurtado J, James L, Wilson W, Braylan RC, Calvo KR, Maric I, Dulau-Florea A, Kreitman RJ. Randomized Phase II Study of First-Line Cladribine With Concurrent or Delayed Rituximab in Patients With Hairy Cell Leukemia. J Clin Oncol. 2020 May 10;38(14):1527-1538. doi: 10.1200/JCO.19.02250. Epub 2020 Feb 28.

  PMID: 32109194 BACKGROUND

• Maitre E, Paillassa J, Troussard X. Novel targeted treatments in hairy cell leukemia and other hairy cell-like disorders. Front Oncol. 2022 Dec 22;12:1068981. doi: 10.3389/fonc.2022.1068981. eCollection 2022.

  PMID: 36620555 BACKGROUND

• Kreitman RJ. Hairy cell leukemia: present and future directions. Leuk Lymphoma. 2019 Dec;60(12):2869-2879. doi: 10.1080/10428194.2019.1608536. Epub 2019 May 9.

  PMID: 31068044 BACKGROUND

MeSH Terms

Conditions

Leukemia, Hairy Cell

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2023

Record last verified: 2023-05