Know Cancer

or
forgot password

Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol


N/A
18 Years
N/A
Open (Enrolling)
Both
Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Lymphomatoid Granulomatosis, Leukemia-Lymphoma, Adult T-Cell

Thank you

Trial Information

Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol


Background:

An estimated 79,190 people living in the United States will be diagnosed with lymphoma in
2012, including 9,060 cases of HL, 70,130 cases of non-Hodgkin's lymphoma (NHL) and multiple
cases of adult T-cell leukemia/lymphoma. Laboratory investigations conducted in the
Metabolism Branch, including analysis of cellular, molecular, genetic and genomic biology
are attempting to develop new prognostic and diagnostic models, therapeutic agents and novel
treatment approaches for lymphoid malignancies and premalignant conditions.

Objectives:

This biology protocol is designed to allow sample acquisition for use in the study of
lymphoid malignancies and malignancy precursors, including but not limited to B and T cell
malignancies, such as diffuse large B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL),
multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma
(ATL). A variety of laboratory investigations will be conducted on blood, tumor, bone
marrow, urine, abnormal fluid and normal tissue, including analysis of cellular, molecular,
genetic and genomic biology in the support of NIH translational trials to develop new
therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic
models.

Eligibility:

Adult patients with confirmed pathological diagnosis of lymphoid malignancy or lymphoid
precursor, including B-cell and T-cell lymphomas: including but not limited to diffuse large
B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL), multiple myeloma (MM), lymphomatoid
granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL).

Design:

The purpose of this study is to examine, in an exploratory fashion, a variety of biologic
assays relevant to the investigation of lymphoid malignancies.

It is anticipated that up to 60 consented subjects, 50 at the NCI site, 10 at the UWI site,
will be studied each year. Thus, an accrual ceiling of 600 consented subjects is planned
over 10 years.

Inclusion Criteria


- INCLUSION CRITERIA:

- Patients with known lymphoid malignancy or precursor disease to a lymphoid
malignancy, including multiple myeloma, B-cell and T-cell lymphomas: including but
not limited to diffuse large B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL),
multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell
leukemia/lymphoma (ATL).

- Confirmed pathological diagnosis.

- At NCI site, the diagnosis is required from the Laboratory of Pathology, NCI.
Tumor tissue that has been previously collected and is available for study or
that can be collected with minimal additional risk to the subject during
sampling required for routine patient care or required testing on an NIH
research protocol will be used for diagnosis.

- At the UWI site, diagnosis is as required per contract HH5N261200800011C.

- Greater than or equal to 18 years of age.

- ECOG performance 0-2.

- Must be willing and able to provide informed consent.

INCLUSION FOR APHERESIS:

- Hemoglobin greater than or equal to 10 milligrams per deciliter and platelet count
greater than 75,000 per cubic millimeter.

- Weight greater than 25 kilograms

- HIV negative

- Prothrombin Time - within normal limits

- Partial Thromboplastin Time - within normal limits

- Medically indicated central line in place or adequate peripheral venous access

EXCLUSION CRITERIA:

- Pregnant or breast feeding women will not be eligible for any aspect of this protocol
except phlebotomy.

- Active symptomatic major organ disorder that would increase the risk of biopsy or
apheresis, including but not limited to ischemic heart disease, recent myocardial
infarction, active congestive heart failure, pulmonary dysfunction.

- Active concomitant medical or psychological illnesses that may increase the risk to
the subject or inability to obtain informed consent, at the discretion of the
principal investigator.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Wyndham H Wilson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

120193

NCT ID:

NCT01676805

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Hodgkin Disease
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Lymphomatoid Granulomatosis
  • Leukemia-Lymphoma, Adult T-Cell
  • Developing Novel Treatment Approaches
  • Developing Therapeutic Agents
  • Analysis of Genetic and Genomic Biology
  • New Prognostic and Diagnostic Models
  • Analysis of Cellular and Molecular Biology
  • Hodgkin Disease
  • Leukemia
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892