Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
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|ClinicalTrials.gov Identifier: NCT01087333|
Recruitment Status : Recruiting
First Posted : March 16, 2010
Last Update Posted : December 23, 2020
- 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.
- 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.
- 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.
- 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.
|Condition or disease|
|Hairy Cell Leukemia (HCL) Chronic Lymphocytic Leukemia (CLL) Non-Hodgkins Lymphoma (NHL) Cutaneous T Cell Lymphoma (CTCL) Adult T Cell Lymphoma (ATL)|
- 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 are being developed by the Laboratory of Molecular Biology (LMB).
- The investigators on this protocol are studying molecular and clinical aspects of HCL, and how they compare to normal or to other disorders, including chronic lymphocytic leukemia (CLL) non-Hodgkin s lymphoma (NHL), and acute lymphoblastic leukemia (ALL).
- Recombinant immunotoxins are fusion proteins containing a bacterial toxin connected to a targeting ligand, like a single-chain antibody or a growth factor. Recombinant immunotoxins currently under clinical development in the LMB include BL22 and a high affinity variant, HA22, targeting CD22, LMB-2, targeting CD25, and SS1P, targeting Mesothelin.
- LMB-2, BL22 and HA22 are being tested in purine analog resistant HCL.
- Other LMB trials include LMB-2 for cutaneous T-cell lymphoma, chronic lymphocytic leukemia (CLL), and adult T-cell leukemia, and HA22 for non-Hodgkin s lymphoma and CLL.
- To allow the collection of a variety of clinical samples, including blood, urine, lymphopheresis samples, and other tissues, to better understand the disease processes which are being studied, or to determine eligibility and/or optimal timing for clinical testing. Specific projects planned may include:
- studying antibodies made against immunotoxins
- quantifying tumor antigens by flow cytometry and other methods
- testing how well recombinant immunotoxins and other agents kill tumor cells ex vivo
- molecularly characterizing malignant B-cells by sequencing their immunoglobulin rearrangements and other genes.
- Samples which are easily obtained, including blood and urine, may be obtained from patients and normal volunteers.
- Samples requiring procedures, including bone marrow biopsy/aspiration, leukopheresis, and any procedure done because of medical need, may be obtained from patients.
- Patients or normal donors are consented for the protocol and samples are obtained.
- This protocol does not involve treatment, although patients may also be on therapy or protocol treatment.
|Study Type :||Observational|
|Estimated Enrollment :||1263 participants|
|Official Title:||Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment|
|Actual Study Start Date :||March 2, 2010|
Patients with hematologic malignancy, including HCL, CLL, CTCL, ATL, NHL, ALL, or solid tumor, including mesothelioma.
Normal Donors who are defined as individuals without a diagnosis of or history of any cancer.
Samples transferred from protocols 07-C-0130 and 08-CN-013
- Tissue Acquisition [ Time Frame: 4 weeks ]Collection of a variety of clinical samples, including blood, urine, lymphopheresis samples, and other tissues and associated data
- Overall survival [ Time Frame: every year ]Time from the start of treatment that patients are still alive
- assessment of tumor burden [ Time Frame: when also needed for medical purposes ]obtain imaging data for assessment of tumor burden
- correlate tumor burden with lab measurements [ Time Frame: when also needed for medical purposes ]correlate tumor burden with lab measurements using imaging data
- define immune response in patients with current or past viral infections [ Time Frame: when also needed for medical purposes ]Define the T- and B-cell repertoire in patients with active or past viral infections, particularly for COVID-19 pandemic
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087333
|Contact: Julie C Feurtado, R.N.||(301) firstname.lastname@example.org|
|Contact: Robert J Kreitman, M.D.||(301) email@example.com|
|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) NCI-1937|
|Principal Investigator:||Robert J Kreitman, M.D.||National Cancer Institute (NCI)|