Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT01087333

Conditions

Hairy Cell Leukemia (HCL)

Chronic Lymphocytic Leukemia (CLL)

Non-Hodgkins Lymphoma (NHL)

Cutaneous T Cell Lymphoma (CTCL)

Adult T Cell Lymphoma (ATL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Hairy Cell Leukemia (HCL)

Chronic Lymphocytic Leukemia (CLL)

Non-Hodgkins Lymphoma (NHL)

Cutaneous T Cell Lymphoma (CTCL)

Adult T Cell Lymphoma (ATL)

Study ID

NCT01087333

Start date

Mar 2, 2010

Status verified date

Jul 6, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

1263 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Tissue Acquisition [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 17, 2026

Last verified

Jul 6, 2026

Keywords

  • Cytotoxicity Assay
  • Neutralizing Antibodies
  • Apheresis
  • Flow Cytometry
  • Hemolytic Uremic Syndrome (HUS)
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-17.