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Protocol Details

A Study of Hairy Cell and other Leukemias with a Focus on Recombinant Immunotoxins for Cancer Treatment

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-C-0066

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women;
Fetuses;
Adults who are or may become unable to consent

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Hairy Cell Leukemia (HCL);
Chronic Lymphocytic Leukemia (CLL);
Non-Hodgkins Lymphoma (NHL);
Cutaneous T Cell Lymphoma (CTCL);
Adult T Cell Lymphoma (ATL)

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert J. Kreitman, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N248A
10 CENTER DR
BETHESDA MD 20892
(301) 648-7375
kreitmar@mail.nih.gov

Julie C. Feurtado, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 12N214
10 Center Drive
Bethesda, Maryland 20892
(301) 480-6186
julie.feurtado@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT01087333

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