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

NCT00689884 | Terminated Results DMC

• 1 other identifier: D0546
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

Study Arms (1)

Group A

EXPERIMENTAL

All eligible patients will receive chemotherapy and one dose of Pegfilgrastim

Drug: Pegfilgrastim

Interventions

Pegfilgrastim DRUG

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).

Also known as: Neulasta

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: John M. Hill, MD - Principal Investigator
• Organization: Dartmouth-Hitchcock Medical Center

john.m.hill@hitchcock.org

603-650-4628

Study Officials

• John M Hill Jr., MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Allogeneic Bone Marrow Transplant Program

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 4, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 20, 2018
• Results First Posted: August 31, 2012

Record last verified: 2018-03

Locations

US (1)