Expired Study
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Lebanon, New Hampshire 03756


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.


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.


Study is Available At:


Original ID:

D0546


NCT ID:

NCT00689884


Secondary ID:


Study Acronym:


Brief Title:

Feasibility and Cost Analysis of PBSC Mobilization Using Pegfilgrastim in Hematologic Malignancies


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dartmouth-Hitchcock Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Lack of enrollment.


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:John M Hill Jr., MD
Principal Investigator
Dartmouth-Hitchcock Medical Center

Study Dates

Start Date:January 2007
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 22, 2018
First Received Date:May 30, 2008
First Results Date:January 16, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants.
Time Frame:At each stage of pheresis for each enrolled subject for a maximum of 2 years.
Safety Issues:False
Description:Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machin
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Study Interventions

Intervention Type:Drug
Name:Pegfilgrastim
Description: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).
Arm Name:Group A
Other Name:Neulasta

Study Arms

Study Arm Type:Experimental
Arm Name:Group A
Description:All eligible patients will receive chemotherapy and one dose of Pegfilgrastim

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dartmouth-Hitchcock Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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