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

Primary Purpose

Hematologic Malignancies

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pegfilgrastim

About this trial

This is an interventional treatment trial for Hematologic Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

All eligible patients will receive chemotherapy and one dose of Pegfilgrastim

Outcomes

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

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

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT00689884

First Posted

May 30, 2008

Last Updated

March 22, 2018

Sponsor

Dartmouth-Hitchcock Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00689884

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment.

Study Start Date

January 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

All eligible patients will receive chemotherapy and one dose of Pegfilgrastim

Intervention Type

Drug

Intervention Name(s)

Pegfilgrastim

Other Intervention Name(s)

Neulasta

Intervention 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).

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants.

Description

Time Frame

At each stage of pheresis for each enrolled subject for a maximum of 2 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John M Hill Jr., MD

Organizational Affiliation

Dartmouth-Hitchcock Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

12. IPD Sharing Statement

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

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