Clinical Trials Logo

Clinical Trial Summary

This protocol is being submitted to consolidate, update, and expand two previously approved protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to examine the factors involved in the regulation of the immune system of healthy individuals and to define the abnormalities in this regulation that underlies the immunological disorders of patients with a variety of immunodeficiency and malignant disorders. The studies will include the ex vivo phenotypic and functional analysis of the network of cells involved in humoral and cellular immune responses, and in vivo testing for the capacity to make delayed-type hypersensitivity and humoral responses following immunization with a variety of antigens. Individuals to be studied will include patients with a variety of malignancies and patients with primary and secondary immunodeficiency disorders. Selected family members or family members known to be genetic carriers of certain immunodeficiency diseases as well as normal, unrelated individuals will also be studied. A small number of procedures will be used including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall antigens and immunization to assess humoral immunity....


Clinical Trial Description

Background: - The evaluation of the cells of the immune system and HTLV-1 infection has been a central focus of the Metabolism Branch for the past 30 years. - Blood obtained by apheresis or blood drawing, skin biopsies and other tissues will be evaluated for abnormalities related to immunity, HTLV-1 infection and the immune system. - Advances in the characterization of acquired genetic changes in tumor samples has led to insights for the development of targeted therapy of malignancy Objectives: - To characterize the molecular biology and immunological features as well as the clinical course of individuals with suspected or known disorders of the immune system or cancer - To define the nature of the immunological, genetic and epigenetic abnormalities in the cells of patients with immunodeficiency diseases associated with infections and/or a high incidence of malignancy and in patients with cancer. - To obtain whole blood, plasma and leukocytes, as well as skin, lymph node and bone marrow biopsies on patients with immunodeficiency or cancer to investigate the immune system. Eligibility: - Subjects with cancer. - Subjects with immunodeficiency. - Subjects with HTLV-1 infection. Design: -This is a natural history study that permits tissue acquisition for analysis of the immune system and HTLV-1 infection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00001582
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date June 7, 1997
Completion date March 17, 2023

See also
  Status Clinical Trial Phase
Completed NCT01413178 - A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma Phase 3
Recruiting NCT03641456 - VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma Phase 2
Completed NCT03135925 - Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation N/A
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Withdrawn NCT02114502 - Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma Phase 2
Completed NCT00794261 - Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma Phase 2
Completed NCT00800839 - Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide Phase 2
Completed NCT01700608 - Prospective Observational Study on Plerixafor After Chemotherapy N/A
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Recruiting NCT05528887 - Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies Phase 1
Recruiting NCT05625971 - Non-invasive MRD Assessment in Multiple Myeloma
Active, not recruiting NCT02931942 - Changing Over Time of Ascorbic Acid After Chemotherapy
Recruiting NCT05889221 - Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Active, not recruiting NCT02542657 - Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Completed NCT01279694 - Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP) Phase 1/Phase 2
Completed NCT01191060 - Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years Phase 3
Terminated NCT00983346 - Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients Phase 2
Completed NCT00476294 - Long-Term Follow Up Study for AMD3100 Patients N/A
Completed NCT00344422 - Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Phase 3