Sammlung menschlicher Proben zur Untersuchung von Haarzellen- und anderen Leukämien und zur Entwicklung rekombinanter Immuntoxine für die Krebsbehandlung
Eine Studie über Haarzellen- und andere Leukämien mit Schwerpunkt auf rekombinanten Immuntoxinen zur Krebsbehandlung
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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Julie C Feurtado, R.N.
- Telefonnummer: (301) 480-6186
- E-Mail: julie.feurtado@nih.gov
Studieren Sie die Kontaktsicherung
- Name: Robert J Kreitman, M.D.
- Telefonnummer: (301) 648-7375
- E-Mail: kreitmar@mail.nih.gov
Studienorte
-
-
Maryland
-
Bethesda, Maryland, Vereinigte Staaten, 20892
- Rekrutierung
- National Institutes of Health Clinical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Primary clinical population; normal donors
Beschreibung
- INCLUSION CRITERIA:
All participants
- 18 years of age and older
- Desire of the individual to submit data and samples for research
- Ability to understand and the willingness to sign a written informed consent document.
Individuals with cancer
-Participants may have a diagnosis of hematologic malignancy or solid tumor. These participants would not be excluded if they were in long-term complete remission.
Normal donors (Individuals without cancer)
-Individuals must not have a current or prior diagnosis of a hematologic malignancy or solid tumor.
EXCLUSION CRITERIA:
All participants
-Known pregnancy at enrollment. NOTE: A pregnancy test will be required in individuals on study prior to any procedure done for research purposes that is greater than minimal risk.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_CONTROL
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
1
Patients with hematologic malignancies or solid tumors. |
|
2
Normal Donors who are defined as individuals without a diagnosis of or history of any cancer. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Tissue Acquisition
Zeitfenster: 4 weeks
|
Collection of a variety of clinical samples, including blood, urine, lymphapheresis samples, and other tissues and associated data |
4 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
HCL follow-up
Zeitfenster: about every 2 years
|
Assess long-term treatment complications and disease outcomes in participants with HCL/HCLv |
about every 2 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Robert J Kreitman, M.D., National Cancer Institute (NCI)
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Kreitman RJ, James L, Feurtado J, Eager H, Sierra Ortiz O, Gould M, Shpilman I, Zhou H, Burbelo PD, Cohen JI, Wang HW, Yuan CM, Arons E. COVID-19 vaccination in patients with classic and variant hairy cell leukemia. Blood Neoplasia. 2024 Aug 28;1(4):100035. doi: 10.1016/j.bneo.2024.100035. eCollection 2024 Dec.
- Arons E, Tai CH, Suraj J, Liu Y, Day CP, Raffeld M, Xi L, Zhou H, Gould M, Shpilman I, Oakes CC, Bhat S, Grever M, Jones D, Rogers K, Wang HW, Yuan CM, Sahinalp C, Kreitman RJ. Non-V600E BRAF mutations and treatment for hairy cell leukemia. Blood. 2025 Apr 24;145(17):1957-1961. doi: 10.1182/blood.2024026894.
- Arons E, Henry K, Haas C, Gould M, Tsintolas J, Mauter J, Zhou H, Burbelo PD, Cohen JI, Kreitman RJ. Characterization of B-cell receptor clonality and immunoglobulin gene usage at multiple time points during active SARS-CoV-2 infection. J Med Virol. 2023 Oct;95(10):e29179. doi: 10.1002/jmv.29179.
- Kreitman RJ, Yu T, James L, Feurtado J, Eager H, Ortiz OS, Gould M, Mauter J, Zhou H, Burbelo PD, Cohen JI, Wang HW, Yuan CM, Arons E. COVID-19 in patients with classic and variant hairy cell leukemia. Blood Adv. 2023 Dec 12;7(23):7161-7168. doi: 10.1182/bloodadvances.2023011147.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Zytopenie
- Pathologische Prozesse
- Neubildungen
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Chronische Erkrankung
- Krankheitsattribute
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Hämatologische Erkrankungen
- Lymphatische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Leukämie, B-Zell
- Lymphom
- Anämie, hämolytisch
- Anämie
- Leukämie, lymphatisch
- Leukämie
- Erkrankungen der Blutplättchen
- Thrombotische Mikroangiopathien
- Thrombozytopenie
- Lymphom, T-Zell
- Urämie
- Vorläuferzelle lymphoblastische Leukämie-Lymphom
- Pathologische Zustände, Anzeichen und Symptome
- Hämische und lymphatische Krankheiten
- Leukämie, lymphozytär, chronisch, B-Zell
- Lymphom, Non-Hodgkin
- Vorläufer-T-Zell-lymphoblastisches Leukämie-Lymphom
- Lymphom, T-Zelle, Haut
- Leukämie, Haarzelle
- Hämolytisch-urämisches Syndrom
Andere Studien-ID-Nummern
- 100066
- 10-C-0066
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD-Sharing-Zeitrahmen
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD-Sharing-Zugriffskriterien
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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