Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
200

Summary

Conditions
  • Adult T Cell Lymphoma (ATL)
  • Chronic Lymphocytic Leukemia (CLL)
  • Cutaneous T Cell Lymphoma (CTCL)
  • Hairy Cell Leukemia (HCL)
  • Non-Hodgkin's Lymphoma (NHL)
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 stud...

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.

Tracking Information

NCT #
NCT01087333
Collaborators
Not Provided
Investigators
Principal Investigator: Robert J Kreitman, M.D. National Cancer Institute (NCI)