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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01087333
First received: March 13, 2010
Last updated: June 28, 2014
Last verified: May 2014
  Purpose

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.

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Tissue Acquisition [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: February 2010
Detailed Description:

Background:

  • 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.

Objectives:

- Primary: To allow the collection of a variety of clinical samples, including blood, urine, lymphopheresis samples, and other tissues, in order to improve the efficacy and safety of recombinant immunotoxins, to better understand the disease processes which are being treated, and to determine eligibility and optimal timing for clinical testing. Specific projects planned include 1) studying antibodies made against immunotoxins, 2) quantifying tumor antigens by flow cytometry, 3) testing how well recombinant immunotoxins kill tumor cells ex vivo, 4) quantifying soluble antigens like CD22 and CD25 in the serum of patients and normal controls, 5) molecularly characterizing malignant B-cells by sequencing their immunoglobulin rearrangements.

Eligibility:

  • 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.

Design:

  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. 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.
    2. Patients and normal volunteer donors must be at least 18 years of age.
    3. Ability to give informed consent.
    4. Samples which are easily obtained, including blood and urine, may be obtained from patients and normal volunteers.
    5. Samples requiring procedures, including bone marrow biopsy/aspiration, leukopheresis, lymph node or tumor aspirate or biopsy, and any procedure done because of medical need, may be obtained from patients.
    6. For patients undergoing leukopheresis for research purposes, the hematocrit must be at least 28% and the platelet count at least 50,000/mm(3).
    7. 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.

Exclusion Criteria for normal donors:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087333

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Robert J Kreitman, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01087333     History of Changes
Other Study ID Numbers: 100066, 10-C-0066
Study First Received: March 13, 2010
Last Updated: June 28, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cytotoxicity Assay
Neutralizing Antibodies
Apheresis
Flow Cytometry
Hemolytic Uremic Syndrome (HUS)
Leukemia
Lymphoma
Hairy Cell Leukemia
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Cutaneous T Cell Lymphoma
Adult T Cell Lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Hairy Cell
Leukemia, Lymphoid
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, T-Cell
Immunotoxins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014