Raccolta di campioni umani per studiare le cellule capellute e altre leucemie e sviluppare immunotossine ricombinanti per il trattamento del cancro
Uno studio sulle cellule capellute e altre leucemie con particolare attenzione alle immunotossine ricombinanti per il trattamento del cancro
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Julie C Feurtado, R.N.
- Numero di telefono: (301) 480-6186
- Email: julie.feurtado@nih.gov
Backup dei contatti dello studio
- Nome: Robert J Kreitman, M.D.
- Numero di telefono: (301) 648-7375
- Email: kreitmar@mail.nih.gov
Luoghi di studio
-
-
Maryland
-
Bethesda, Maryland, Stati Uniti, 20892
- Reclutamento
- National Institutes of Health Clinical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Primary clinical population; normal donors
Descrizione
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_CONTROL
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
|---|
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tissue Acquisition
Lasso di tempo: 4 weeks
|
Collection of a variety of clinical samples, including blood, urine, lymphapheresis samples, and other tissues and associated data |
4 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HCL follow-up
Lasso di tempo: about every 2 years
|
Assess long-term treatment complications and disease outcomes in participants with HCL/HCLv |
about every 2 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Robert J Kreitman, M.D., National Cancer Institute (NCI)
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Citopenia
- Processi patologici
- Neoplasie
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattia cronica
- Attributi della malattia
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Leucemia, cellule B
- Linfoma
- Anemia, emolitico
- Anemia
- Leucemia, linfoide
- Leucemia
- Disturbi delle piastrine del sangue
- Microangiopatie trombotiche
- Trombocitopenia
- Linfoma, cellule T
- Uremia
- Leucemia-linfoma linfoblastico a cellule precursori
- Condizioni patologiche, segni e sintomi
- Malattie emiche e linfatiche
- Leucemia, linfocitica, cronica, cellule B
- Linfoma non Hodgkin
- Leucemia-linfoma linfoblastico a cellule T precursore
- Linfoma, cellule T, cutaneo
- Leucemia, cellule capellute
- Sindrome Emolitico-Uremica
Altri numeri di identificazione dello studio
- 100066
- 10-C-0066
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .