Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01087333 |
| Other study ID # |
100066 |
| Secondary ID |
10-C-0066 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2010 |
Study information
| Verified date |
June 3, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
Julie C Feurtado, R.N. |
| Phone |
(301) 480-6186 |
| Email |
julie.feurtado[@]nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
- Researchers who are studying hairy cell leukemia, and how the disease compares with other
disorders, are interested in obtaining additional samples from leukemia patients and healthy
volunteers. The investigators are particularly interested in samples from individuals who
have diseases that can be treated with a new type of drug called immunotoxin, in which an
antibody carrying a toxin binds to a cancer cell and allows the toxin to kill the cell.
Objectives:
- To collect a variety of clinical samples, including blood, urine, lymph samples, and other
tissues, in order to study the samples and develop new treatments for leukemia.
Eligibility:
- Individuals 18 years of age and older who have been diagnosed with leukemia or other kinds
of blood and lymphatic system cancers, or who are healthy volunteers.
Design:
- Individuals who have leukemia will be asked to provide blood, bone marrow, urine, and
tumor tissue samples as requested by the researchers. Healthy volunteers will provide
only blood and urine samples.
- No treatment will be given as part of this protocol.
Description:
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.
