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

  • participants needed
  • sponsor
    National Cancer Institute (NCI)
Updated on 21 April 2021
platelet count
hematologic malignancy
cancer treatment
solid tumor


  • 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.


  • 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.

Condition Hairy Cell Leukemia, Lymphoma, cutaneous T-cell lymphoma, Chronic Lymphocytic Leukemia, Adult T-cell leukemia, T-Cell Lymphoma, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl), leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma
Clinical Study IdentifierNCT01087333
SponsorNational Cancer Institute (NCI)
Last Modified on21 April 2021


Yes No Not Sure

Inclusion Criteria

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 leukapheresis 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

Exclusion Criteria

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
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
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