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

• ClinicalTrials.gov Identifier: NCT00689884
• Recruitment Status: Terminated
• First Posted: June 4, 2008
• Results First Posted: August 31, 2012
• Last Update Posted: April 20, 2018
• Sponsor: Dartmouth-Hitchcock Medical Center
• Information provided by (Responsible Party): John M. Hill, Jr., MD, Dartmouth-Hitchcock Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hematologic Malignancies	Drug: Pegfilgrastim	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies
• Study Start Date: January 2007
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A; All eligible patients will receive chemotherapy and one dose of Pegfilgrastim	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).; Other Name: Neulasta

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Secondary Outcome Measures :

1. 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. ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: John M. Hill, Jr., MD, Director, Allogeneic Bone Marrow Transplant Program, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT00689884
• Other Study ID Numbers: D0546
• First Posted: June 4, 2008
• Results First Posted: August 31, 2012
• Last Update Posted: April 20, 2018
• Last Verified: March 2018

Additional relevant MeSH terms:

Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Hematologic Diseases