- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05859932
Assessing Medical Trial Experiences of Hairy Cell Leukemia Patients
A Look at the Patterns in Clinical Research Participation Among Patients With Hairy Cell Leukemia
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Michael B Gill
- Phone Number: 415-900-4227
- Email: bask@withpower.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients who decide to enroll in a hairy cell leukemia clinical study.
Time Frame: 3 months
|
3 months
|
Number of hairy cell leukemia study participants who remain in clinical trial until completion.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81405664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hairy Cell Leukemia
-
National Cancer Institute (NCI)Active, not recruitingHairy Cell Leukemia | Recurrent Hairy Cell Leukemia | Hairy Cell Leukemia VariantUnited States
-
National Cancer Institute (NCI)RecruitingHairy Cell Leukemia | Hairy Cell Leukemia VariantUnited States
-
Memorial Sloan Kettering Cancer CenterYale University; Dana-Farber Cancer InstituteActive, not recruitingLeukemia | Leukemia, Hairy Cell | Hairy Cell LeukemiaUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Northwestern University; Northwell Health; Dana-Farber... and other collaboratorsActive, not recruitingHairy Cell LeukemiaUnited States
-
MedImmune LLCCambridge Antibody TechnologyCompletedHairy Cell LeukemiaUnited States, Poland
-
National Cancer Institute (NCI)TerminatedHairy Cell LeukemiaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHairy Cell Leukemia | Recurrent Hairy Cell LeukemiaUnited States
-
Jurgen BarthCompletedHairy Cell Leukemia (HCL)Germany
-
National Cancer Institute (NCI)Not yet recruitingRecurrent Hairy Cell Leukemia | Recurrent Hairy Cell Leukemia Variant
-
AstraZenecaApproved for marketingRelapsed/Refractory Hairy Cell Leukemia