Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment

Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment


Lead sponsor: National Cancer Institute (NCI)

Source National Institutes of Health Clinical Center (CC)
Brief Summary


- 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.


- 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.


- 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.


- 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.

Detailed Description


- 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 are being developed by the Laboratory of Molecular Biology (LMB).

- The investigators on this protocol are studying molecular and clinical aspects of HCL, and how they compare to normal or to other disorders, including chronic lymphocytic leukemia (CLL) non-Hodgkin s lymphoma (NHL), and acute lymphoblastic leukemia (ALL).

- Recombinant immunotoxins are fusion proteins containing a bacterial toxin connected to a targeting ligand, like a single-chain antibody or a growth factor. Recombinant immunotoxins currently under clinical development in the LMB include BL22 and a high affinity variant, HA22, targeting CD22, LMB-2, targeting CD25, and SS1P, targeting Mesothelin.

- LMB-2, BL22 and HA22 are being tested in purine analog resistant HCL.

- Other LMB trials include LMB-2 for cutaneous T-cell lymphoma, chronic lymphocytic leukemia (CLL), and adult T-cell leukemia, and HA22 for non-Hodgkin s lymphoma and CLL.


- To allow the collection of a variety of clinical samples, including blood, urine, lymphopheresis samples, and other tissues, to better understand the disease processes which are being studied, or to determine eligibility and/or optimal timing for clinical testing. Specific projects planned may include:

- studying antibodies made against immunotoxins

- quantifying tumor antigens by flow cytometry and other methods

- testing how well recombinant immunotoxins and other agents kill tumor cells ex vivo

- molecularly characterizing malignant B-cells by sequencing their immunoglobulin rearrangements and other genes.


- Samples which are easily obtained, including blood and urine, may be obtained from patients and normal volunteers.

- Samples requiring procedures, including bone marrow biopsy/aspiration, leukopheresis, and any procedure done because of medical need, may be obtained from patients.


- Patients or normal donors are consented for the protocol and samples are obtained.

- This protocol does not involve treatment, although patients may also be on therapy or protocol treatment.

Overall Status Recruiting
Start Date February 16, 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Tissue Acquisition 4 weeks
Secondary Outcome
Measure Time Frame
Overall survival every year
assessment of tumor burden when also needed for medical purposes
correlate tumor burden with lab measurements when also needed for medical purposes
Enrollment 1263

Sampling method: Non-Probability Sample



- Patients may have a diagnosis of hematologic malignancy, including HCL, CLL, CTCL, ATL, NHL, ALL, or solid tumor, including mesothelioma. These patients would not be excluded if they were in complete remission or thought to be cured of their malignancy.

- Patients and normal volunteer donors must be at least 18 years of age and able to give informed consent. Informed consent will be waived for patient samples transferred from other protocols.

- For patients undergoing leukopheresis for research purposes, the hematocrit must be at least 28% and the platelet count at least 50,000/mm(3).

- Inclusion of Women and Minorities-Both men and women and members of all races and ethnic groups are eligible for this trial.


Desire of the patient or normal donor not to submit samples.


- Heart, lung, kidney disease, or bleeding disorders.

- Diagnosis of cancer

- Hepatitis since age 11.

- Pregnancy

- History of HIV infection or AIDS

- History of high-risk activities for exposure to the AIDS virus, including:

- Receipt of money or drugs in exchange for sex in the past 5 years.

- Use of needles to take drugs, steroids, or anything not prescribed by a physician in the past 5 years

- Sexual contact in past 12 months with anyone having these high-risk activities or anyone whose status is unknown.

- Symptoms of AIDS or other infection in past 12 months including:

- Unexplained weight loss or night sweats

- Blue or purple spots in the mouth or skin

- White spots or unusual sores in the mouth

- Persistent cough or shortness of breath

- Chronic diarrhea

- Fever of more than 100.5 degrees F for more than 10 days

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Robert J Kreitman, M.D. Principal Investigator National Cancer Institute (NCI)
Overall Contact

Last name: Julie C Feurtado, R.N.

Phone: (301) 480-6186

Email: [email protected]

facility status contact National Institutes of Health Clinical Center, 9000 Rockville Pike For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937
Location Countries

United States

Verification Date

May 13, 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 1

Description: Patients with hematologic malignancy, including HCL, CLL, CTCL, ATL, NHL, ALL, or solid tumor, including mesothelioma.

Arm group label: 2

Description: Healthy Volunteers

Study Design Info

Observational model: Case-Control

Time perspective: Prospective