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The Characterization of CD34+ Derived Mast Cell Precursors Mobilized by Administration of Granulocyte Colony Stimulating Factor and Plerixafor


N/A
18 Years
60 Years
Open (Enrolling)
Both
Mastocytosis

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Trial Information

The Characterization of CD34+ Derived Mast Cell Precursors Mobilized by Administration of Granulocyte Colony Stimulating Factor and Plerixafor


The purpose of this protocol is to obtain large numbers of CD34+ cells from the peripheral
blood of healthy volunteers and patients with systemic mastocytosis or other related
allergic, hematological, and immunological conditions by leukapheresis for culture and
characterization of mast cell progenitor cells and their response to various cytokines and
anti-mitotic agents. Healthy volunteers and patients will be adults of both sexes from 18 to
60 years of age. Granulocyte colony stimulating factor (G-CSF) will be administered to
healthy volunteers at dose of 10 mcg/kg/day as a subcutaneous dose daily for 5 days not to
exceed 960mcg. Patients will receive Plerixafor at a dose of 0.24 mg/kg as a single
subcutaneous dose not to exceed 24mg the night before leukapheresis as a mobilizing agent
for CD34+ cells. Healthy volunteers will undergo a single leukapheresis at day 7, and
patients will undergo a single leukapheresis at day 3 or 4. This is not a therapeutic
protocol and does not involve reinfusion of any manipulated cells, viruses or DNA constructs
back into human subjects.

Inclusion Criteria


- SUBJECT INCLUSION CRITERIA:

Healthy Volunteers must:

1. Be 18-60 years of age

2. Be healthy

3. Have adequate peripheral venous access

4. Have normal renal function (creatinine less than or equal to 1.5mg/dL; less than or
equal to 1 plus proteinuria)

5. Have normal hepatic function (bilirubin less than or equal to 1.5 mg/dL)

6. Have normal hematologic function (WBC greater than or equal to 3000/mm(3);
granulocytes greater than or equal to 1500/mm(3) ; platelets greater than or equal to
175,000; hemoglobin greater than or equal to 12.5 g/dL)

Patients must:

1. Be 18-60 years of age

2. Have mast cell hyperplasia compatible with a diagnosis of systemic mastocytosis
(applicable to systemic mastocytosis patients only) or other allergic, hematologic,
or immunologic condition

3. Have adequate peripheral venous access or be willing to have a central line placed.

4. First be admitted as inpatients under an existing NIH protocol

5. Have preserved renal function (creatinine less than or equal to 2 mg/dL; less than or
equal to 2 plus proteinuria)

6. Have preserved hepatic function (bilirubin less than or equal to 1.5 mg/dL)

7. Have preserved hematologic function (WBC greater than or equal to 3000/mm(3);
granulocytes greater than or equal to 1500/mm(3) ; platelets greater than or equal to
175,000; hemoglobin greater than or equal to 12.5 g/dL)

All female subjects of childbearing potential:

1. May be enrolled if using effective contraception

2. Have a negative serum or urine pregnancy test determined before beginning Plerixafor
or G-CSF administration

SUBJECT EXCLUSION CRITERIA:

All subjects must not meet any of the following criteria:

Healthy volunteers and patients must not:

1. Have active bacterial, fungal or viral infections

2. Have viral screens positive for HIV or hepatitis B or C

3. Be pregnant or lactating

4. Have a history of autoimmune disease such as rheumatoid arthritis, vasculitis,
pyoderma gangrenosum or similar disorder

5. Have any condition, which in the judgment of the investigator, might place the
subject at undue risk

Healthy Volunteers with any of the following will be excluded:

1. Splenomegaly, pulmonary fibrosis and other related conditions

2. Use of any investigative drugs within the past 12 months

3. Have a significant coagulation disorder

Systemic Mastocytosis and Mast Cell Related Condition Patients with any of the following
will be excluded:

1. Patients taking any other growth factors, cytokines or investigative drugs

2. Patients who are hemodynamically unstable (blood pressure systolic of lower than 105
or diastolic lower than 65)

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Hirsh D Komarow, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Allergy and Infectious Diseases (NIAID)

Authority:

United States: Federal Government

Study ID:

980027

NCT ID:

NCT00001756

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Mastocytosis
  • Leukapheresis
  • Mastocytosis
  • G-CSF
  • Mast Cells
  • Progenitors
  • Normal Volunteer
  • Systemic Mastocytosis
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma

Name

Location

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