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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hematologic Malignancies

Intervention / Treatment
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* Drug: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with hematologic malignancies undergoing stem cell mobilization in association with chemotherapy, prior to autologous stem cell transplantation. Prior Treatment:No parenteral cytotoxic chemotherapy within 2 weeks prior to initiation of chemo-mobilization therapy. Performance Status: Karnofsky > 70% Age >18 Life Expectancy > 4 months Bone Marrow: bone marrow biopsy and aspirate 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. Pulmonary function tests: DLCO > 55% predicted. Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or echocardiography. Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) < 3 x normal (unless believed to be elevated due to disease). 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. 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. No significant established splenomegaly (i.e. spleen size > 20 cm) 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: 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 Medical, social, or psychological factors that would prevent the patient from receiving or cooperating with the full course of therapy. Evidence on physical exam, LP, CT, or MRI scan of CNS involvement with malignancy. 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. Serology positive for HIV. Positive pregnancy test or presence of lactation. Uncontrolled active infection. Documented hypersensitivity to any of the drugs used in the protocol. No concomitant,ongoing malignancy that is life-threatening, based on PI's evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>All eligible patients will receive chemotherapy and one dose of Pegfilgrastim | Drug: Pegfilgrastim<br>* 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).<br>* Other names: Neulasta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg | Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants. | 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 machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration). | At each stage of pheresis for each enrolled subject for a maximum of 2 years. |