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The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells From Normal Volunteers and Volunteers With Lymphoid or Hematologic Malignancies


N/A
N/A
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia, Healthy, Hematologic Neoplasm, Lymphoma

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Trial Information

The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells From Normal Volunteers and Volunteers With Lymphoid or Hematologic Malignancies


Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with
chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is
available as a treatment option to only a minority of patients. Autologous BMT, coupled
with high dose chemotherapy, is a treatment open to more patients and is a promising
strategy for the treatment of advanced solid malignancies. However, the development of
potentially curative marrow transplant alternatives requires an ability to provide a
nonmalignant hematopoietic stem cell population. In addition, the generation of
hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate
all of the cell lineage subtypes following reinfusion are critical to understanding the
biology and immunological consequences of stem cell transplantation. An increased
understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the
identification of donor cell populations that mediate a graft versus leukemia (GVL) effect
or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these
currently unmet objectives, normal volunteers and volunteers with malignancies will undergo
venipuncture and bone marrow aspiration with or without prior [6,6-(2)H2] or
[U-(13)C9]-glucose, infusion to provide cell populations which will then be utilized for
specific pre-clinical studies aimed at developing new therapeutic alternatives for patients
with CML and other lymphoid/hematologic malignancies. An infusion of [6,6-(2)H2] or
[U-(13)C9]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will
allow direct examination of the genesis and biology of stem cells and leukocyte
subpopulations. [6,6-(2)H2] or [U-(13)C9]-glucose, are nonradioactive, stable isotopes of
glucose which will label dividing cells during the time of administration and is chemically
identical to glucose, with no adverse side effects other than those known for glucose.

Inclusion Criteria


INCLUSION CRITERIA:

All volunteers at the Clinical Center will be recruited through and registered with the
NIH Volunteer Office. Volunteers at collaborating institutions will be recruited through
Associate Investigators at that institution according to institutionally IRB approved
methods.

All volunteers may be normal volunteers or have a diagnosis of a lymphoid/hematologic
malignancy (chronic myelogenous leukemia, multiple myeloma, lymphoma, acute myelogenous
leukemia, chronic lymphocytic leukemia, acute lymphocytic leukemia).

To be eligible peripheral blood apheresis, all normal volunteers must have a hematocrit of
greater than or equal to 36% and a peripheral platelet count of greater than or equal to
100,000/mm(3). Volunteers with a lymphoid/hematologic malignancy must have a hematocrit
of greater than or equal to 30% and a peripheral platelet count of greater than or equal
to 100,000/mm(3). All volunteers, including those volunteers with lymphoid/hematologic
malignancies, must have a white blood cell count of greater than or equal to 4,000/mm(3).
Volunteers with a lymphoid/hematologic malignancy must have a white blood cell count of
less than 100,000/mm(3).

To be eligible for venipuncture or bone marrow aspiration, normal volunteers and
volunteers with lymphoid/hematologic malignancies must have no history of an abnormal
bleeding tendency or documented predisposition to infection. For venipuncture and bone
marrow aspiration, the peripheral blood platelet count of normal volunteers must be
greater than 100,000/mm(3) and for volunteers with a lymphoid/hematologic malignancy, the
platelet count must be greater than or equal to 50,000/mm(3).

All normal volunteers and volunteers with a lymphoid/hematologic malignancy are eligible
to receive apheresis (done only at the NIH Clinical Center), bone marrow sampling, or
venipuncture. Apheresis will only be performed at the Clinical Center of the National
Institutes of Health. Apheresis will not be peformed at collaborating institutions.

Normal volunteers and volunteers with lymphoid/hematopoietic malignancies may donate
samples by apheresis, venipuncture, and bone marrow sampling on multiple occasions.
Repeated donation by apheresis will be allowed as long as a period of at least eight week
has elapsed since a previous apheresis. Repeated donations of peripheral blood or bone
marrow will be allowed as long as a period of at least four weeks has elapsed since a
previous donation. For any given volunteer, the total number of aphereses will not
exceed six per year and the total number of peripheral blood or bone marrow donations will
not exceed eight per year. All normal and CML volunteers must undergo repeat physical
examination and complete blood count evaluation to determine eligibility prior to
donation.

Normal volunteers and volunteers with lymphoid/hematologic malignancies will not be tested
for HIV or hepatitis to determine eligibility for this protocol. However, DTM guidelines
will require that patients undergoing apheresis with subsequent ex vivo elutriation of the
collected products will be required to have testing for HIV and hepatitis B and C.
Volunteers who are required to be tested for HIV and Hepatitis will be informed at the
time of enrollment and will sign an appropriate informed consent for these tests.
Volunteers who are found to be HIV positive or hepatitis B or C can still donate blood
products, but these products will not be subjected to ex vivo elutriation.

Volunteers with lymphoid/hematologic malignancies may be receiving therapy such as
chemotherapy or chronic interferon alpha injections.

EXCLUSION CRITERIA:

Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with significant
history of cardiac, renal, pulmonary, or neurologic disease will be ineligible.

Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with a known
history of HIV or hepatitis B or C will be ineligible.

Any normal volunteer or volunteer with a lymphoid/hematologic malignancy requiring chronic
anticoagulation or steroid therapy will be ineligible.

Any volunteer with a lymphoid/hematologic malignancy with a peripheral blast count that
exceeds 25% or a total lymphocyte count that exceeds 100,000/mm(3) will be ineligible for
apheresis.

Volunteers with a lymphoid/hematologic malignancy who are currently enrolled in an
experimental therapy on an NCI protocol will be ineligible.

Any normal volunteer or volunteer with a lymphoid/Hematologic malignancy with known AIDS
and/or hepatitis B or C will be excluded.

Volunteers with a history of diabetes mellitus will be excluded from receiving [6,6-(2)H]
or [U-(13)C9]-glucose infusions.

A pregnancy test will be given to all female volunteers and volunteers who are pregnant
will be excluded from the study.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

950086

NCT ID:

NCT00001432

Start Date:

March 1995

Completion Date:

November 2003

Related Keywords:

  • Chronic Myeloid Leukemia
  • Healthy
  • Hematologic Neoplasm
  • Lymphoma
  • Purging
  • Apheresis
  • Long Term Culture
  • T Cells
  • Stem Cell
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Hematologic Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892