Hairy Cell Leukemia Clinical Trial
Official title:
A Look at the Patterns in Clinical Research Participation Among Patients With Hairy Cell Leukemia
| NCT number | NCT05859932 |
| Other study ID # | 81405664 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2024 |
| Est. completion date | June 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | June 2026 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patients who decide to enroll in a hairy cell leukemia clinical study. | 3 months | ||
| Primary | Number of hairy cell leukemia study participants who remain in clinical trial until completion. | 12 months |
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