Background
- Hairy cell leukemia (HCL) is highly responsive to but not curable by standard
chemotherapy, and also responds well to investigational agents called recombinant
immunotoxins which have been developed by the Laboratory of Molecular Biology (LMB).
- HCL variants often resemble classic HCL but are more aggressive and less responsive
to treatments, such as HCLv and IGHV4-34+ HCL that are immunophenotypically
indistinguishable from classic HCL and highly aggressive and resistant like HCLv.
- The investigators on this protocol are studying molecular and clinical aspects of
HCL, and how they compare to normal or to other disorders, including other
hematologic malignancies and solid tumors.
- The LMB are also studying agents for HCL/HCLv, including recombinant immunotoxins
developed in the LMB. Specific targets and agents include BL22 and a high affinity
variant, HA22 or Moxetumomab Pasudotox (Moxe), targeting CD22, LMB-2, targeting
CD25, and SS1P, targeting Mesothelin as well as single agents and combinations of
purine analogs (e.g., cladribine, pentostatin, and bendamustine), anti-CD20
monoclonal antibodies (e.g., rituximab), and small molecule inhibitors (e.g., BRAF
V600E inhibitors dabrafenib and encorafenib, MEK inhibitors trametinib and
binimetinib, and Bruton s tyrosine kinase (BTK) inhibitor ibrutinib).
- Longitudinal evaluation of HCL is needed as a basis to identify more effective
treatments.
Objective
-To allow the collection and analysis of a variety of samples, including blood, tumor and
other tissues from individuals with and without cancer to better understand the disease
processes which are being studied, particularly hairy cell leukemia, or to determine
eligibility and/or optimal timing for clinical testing
Eligibility
- Greater than or equal to 18 years of age
- Diagnosis of a hematologic malignancy or solid tumor; or normal donors (i.e.,
individuals without a known malignancy).
Design
- Collection of data and samples for research, including blood, tumor, and other
tissues from participants and normal volunteers.
- Samples may be obtained prior to/after treatment, during disease assessments, and at
the time of response/relapse. This protocol does not involve treatment, although
participants may receive treatment as standard of care or as part of another
research protocol during participation.
- Samples can be obtained at NIH or at local providers (and sent to NIH).
- Systematic follow-up of participants with HCL, in particular those who have
completed prior treatment.
- We anticipate accruing 1263 participants on this protocol.
