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A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies

18 Years
Not Enrolling
Hematologic Malignancies

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Trial Information

A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies

Inclusion Criteria:

1. All patients with hematologic malignancies undergoing stem cell mobilization in
association with chemotherapy, prior to autologous stem cell transplantation.

2. Prior Treatment:No parenteral cytotoxic chemotherapy within 2 weeks prior to
initiation of chemo-mobilization therapy.

3. Performance Status: Karnofsky > 70%

4. Age >18

5. Life Expectancy > 4 months

6. Bone Marrow: bone marrow biopsy and aspirate

7. Blood counts: The patient must have adequate bone marrow function, i.e. a total WBC
of > 2,000/ul, a Hgb of > 7 g/dl, and a platelet count of > 50,000/ul, unless this
abnormality is believed to be due to the underlying disease.

8. Pulmonary function tests: DLCO > 55% predicted.

9. Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or

10. Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) < 3 x normal
(unless believed to be elevated due to disease).

11. Renal function (24 hour urine for creatinine clearance, if clinically indicated):
The patient must have adequate renal function (creatinine clearance >50 ml/min),
except when renal insufficiency is felt related to the underlying malignancy.

12. No significant co-morbid medical or psychiatric illness that would significantly
compromise the patient's clinical care and chances of survival in the transplant

13. No significant established splenomegaly (i.e. spleen size > 20 cm)

14. Informed written consent must be obtained. Patients must be able to give informed
consent as a prerequisite to this procedure. The Informed Consent form will become
part of his/her permanent record and a copy will be given to the patient.

Exclusion Criteria:

1. Patients with greater than three pre-transplant chemotherapy regimens and/or poor
stem cell reserve as demonstrated by significant marrow hypocellularity (<20%) will
not be mobilized on the first phase regimen

2. Medical, social, or psychological factors that would prevent the patient from
receiving or cooperating with the full course of therapy.

3. Evidence on physical exam, LP, CT, or MRI scan of CNS involvement with malignancy.

4. Uncontrolled or severe cardiovascular disease, including recent (< 6 months)
myocardial infarction, congestive heart failure, angina (symptomatic despite optimal
medical management), life-threatening dysrhythmia, or clinically significant
obstructive/restrictive pulmonary disease.

5. Serology positive for HIV.

6. Positive pregnancy test or presence of lactation.

7. Uncontrolled active infection.

8. Documented hypersensitivity to any of the drugs used in the protocol.

9. No concomitant,ongoing malignancy that is life-threatening, based on PI's evaluation.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg

Outcome Description:

Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

John M Hill Jr., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

January 2009

Related Keywords:

  • Hematologic Malignancies
  • Neoplasms
  • Hematologic Neoplasms



Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756