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A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies
This study has been completed.
First Received: May 30, 2008   Last Updated: April 24, 2009   History of Changes
Sponsor: Dartmouth-Hitchcock Medical Center
Information provided by: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00689884
  Purpose

The purpose of this study is to determine the efficacy of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg and to assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs. Also to determine the side effects of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells.


Condition Intervention
Hematologic Malignancies
Drug: Pegfilgrastim

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Efficacy of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determine the side effects of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pegfilgrastim
    Pegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 echocardiography.
  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 setting.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689884

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: John M Hill Jr., MD Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center ( John Hill Jr., MD )
Study ID Numbers: D0546
Study First Received: May 30, 2008
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00689884     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on February 08, 2010