Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01087333 |
|
Recruitment Status :
Recruiting
First Posted : March 16, 2010
Last Update Posted : April 4, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease |
|---|
| Hairy Cell Leukemia (HCL) Chronic Lymphocytic Leukemia (CLL) Non-Hodgkins Lymphoma (NHL) Cutaneous T Cell Lymphoma (CTCL) Adult T Cell Lymphoma (ATL) |
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 |
| Estimated Enrollment : | 1263 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment |
| Actual Study Start Date : | February 16, 2010 |
| Group/Cohort |
|---|
|
1
Patients with hematologic malignancy, including HCL, CLL, CTCL, ATL, NHL, ALL, or solid tumor, including mesothelioma.
|
|
2
Healthy Volunteers
|
- Tissue Acquisition [ Time Frame: 4 weeks ]Collection of a variety of clinical samples, including blood, urine, lymphopheresis samples, and other tissues
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- 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 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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087333
| Contact: Laura Wisch, R.N. | (301) 480-6194 | laura.wisch@nih.gov | |
| Contact: Robert J Kreitman, M.D. | (301) 480-6187 | kreitmar@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
| Principal Investigator: | Robert J Kreitman, M.D. | National Cancer Institute (NCI) |
Additional Information:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01087333 History of Changes |
| Other Study ID Numbers: |
100066 10-C-0066 |
| First Posted: | March 16, 2010 Key Record Dates |
| Last Update Posted: | April 4, 2019 |
| Last Verified: | January 2, 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
|
Cytotoxicity Assay Neutralizing Antibodies Apheresis Flow Cytometry Hemolytic Uremic Syndrome (HUS) |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Leukemia, Hairy Cell Lymphoma, T-Cell, Cutaneous Leukemia-Lymphoma, Adult T-Cell Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, T-Cell Immunotoxins Immunologic Factors Physiological Effects of Drugs |