Clinical trial · Observational
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
A Study of Hairy Cell and Other Leukemias With a Focus on Recombinant Immunotoxins for Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult T Cell Lymphoma (ATL) | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Cutaneous T Cell Lymphoma (CTCL) | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.85 |
| Hairy Cell Leukemia (HCL) | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.85 |
| Non-Hodgkins Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Patients with hematologic malignancies or solid tumors.
- label
- 2
- description
- Normal Donors who are defined as individuals without a diagnosis of or history of any cancer.
Primary outcomes (1)
- measure
- Tissue Acquisition
- timeFrame
- 4 weeks
- description
- Collection of a variety of clinical samples, including blood, urine, lymphapheresis samples, and other tissues and associated data
Secondary outcomes (1)
- measure
- HCL follow-up
- timeFrame
- about every 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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.
References
Publications (4)
- DERIVEDKreitman 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. PMID 40552139
- DERIVEDArons 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. PMID 39719040
- DERIVEDArons 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. PMID 37877800
- DERIVEDKreitman 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. PMID 37729613