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

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ClinicalTrials.gov Identifier: NCT01087333
Recruitment Status : Recruiting
First Posted : March 16, 2010
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date March 13, 2010
First Posted Date March 16, 2010
Last Update Posted Date April 12, 2021
Actual Study Start Date March 2, 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: January 1, 2020)
Tissue Acquisition [ Time Frame: 4 weeks ]
Collection of a variety of clinical samples, including blood, urine, lymphopheresis samples, and other tissues and associated data
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: December 22, 2020)
  • Overall survival [ Time Frame: every year ]
    Time from the start of treatment that patients are still alive
  • assessment of tumor burden [ Time Frame: when also needed for medical purposes ]
    obtain imaging data for assessment of tumor burden
  • correlate tumor burden with lab measurements [ Time Frame: when also needed for medical purposes ]
    correlate tumor burden with lab measurements using imaging data
  • define immune response in patients with current or past viral infections [ Time Frame: when also needed for medical purposes ]
    Define the T- and B-cell repertoire in patients with active or past viral infections, particularly for COVID-19 pandemic
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Official Title Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment
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.
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:

- 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.

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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary clinical population; normal donors
Condition
  • Hairy Cell Leukemia (HCL)
  • Chronic Lymphocytic Leukemia (CLL)
  • Non-Hodgkins Lymphoma (NHL)
  • Cutaneous T Cell Lymphoma (CTCL)
  • Adult T Cell Lymphoma (ATL)
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Patients with hematologic malignancy, including HCL, CLL, CTCL, ATL, NHL, ALL, or solid tumor, including mesothelioma.
  • 2
    Normal Donors who are defined as individuals without a diagnosis of or history of any cancer.
  • 3
    Samples transferred from protocols 07-C-0130 and 08-CN-013
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 2, 2017)
1263
Original Estimated Enrollment
 (submitted: March 13, 2010)
200
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Julie C Feurtado, R.N. (301) 480-6186 julie.feurtado@nih.gov
Contact: Robert J Kreitman, M.D. (301) 480-6187 kreitmar@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01087333
Other Study ID Numbers 100066
10-C-0066
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Robert J Kreitman, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 21, 2020