Study of Ibrutinib for Treatment of Relapsed Hairy Cell Leukemia
- Hairy cell leukemia (HCL) and variant HCL (HCLv) are two uncommon disorders. Many treatments that help people with other specific types of cancer also help people with HCL or vHCL. The anti-cancer drug ibrutinib, which is taken as a pill, has helped treat the other specific cancers. Researchers want to find out if it also helps treat HCL and HCLv.
- To test the safety and benefits of ibrutinib in people with HCL or HCLv.
- Adults age 18 and older with HCL or HCLv that has not responded to standard treatment.
- Participants will be screened with medical history, physical exam, and blood tests. They may have an EKG, a measure of heart rhythm by small sticky patches placed on the skin. They will also have:
- Ultrasound or CT scan. For CT: a substance will be injected through a tube in the arm. Participants will lie on a table in a large, donut-shaped machine. An X-ray tube will move around their body, taking pictures.
- Bone marrow biopsy: A sample of marrow, blood, and bone will be taken by needle from the hip bone.
- Each study cycle will last 28 days.
- Participants will take the study drug once daily and keep a medicine diary.
- Participants will visit their doctor for physical exam and blood tests 4 times in cycle 1 and 1 time every other cycle.
- Participants will have a bone marrow biopsy and body scan before cycles 9 and 13.
- After they leave the study, participants will have follow-up visits every 3 months.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 for Treatment of Relapsed Hairy Cell Leukemia|
- Response Rate [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Rate of molecular remission [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
|Contact: Elizabeth J Maestri, R.N.||(301) email@example.com|
|Contact: Robert J Kreitman, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Robert J Kreitman, M.D.||National Cancer Institute (NCI)|