Hematologic MalignanciesNCT00689884

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

A study testing Pegfilgrastim in people with Hematologic Malignancies, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematologic Malignancies
What is being tested?: Pegfilgrastim
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Jan 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

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

Conditions: Hematologic Malignancies
Being tested: Pegfilgrastim
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegfilgrastimDrug
Also called Neulasta
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).

Study groups in NCT00689884
Study group	Role	What they receive
Group A	Experimental	All eligible patients will receive chemotherapy and one dose of Pegfilgrastim Receives: Drug: Pegfilgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jan 2009

First posted4 Jun 2008 (estimated)
Study startJan 2007
Primary completionJan 2009
Study completionJan 2009

Why it stopped: Lack of enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689884
Sponsor's protocol ID: D0546
Status last verified: Mar 2018
First submitted: 30 May 2008
Last updated: 20 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hematologic Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Feasibility and Cost Analysis of Peripheral Blood Stem Cell Mobilization Using Pegfilgrastim in Patients With Hematologic Malignancies
ClinicalTrials.gov ID: NCT00689884
Acronym / sponsor ID: D0546
Conditions: Hematologic Malignancies
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of enrollment.
Enrolment: 7 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Study start: Jan 2007
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 4 Jun 2008 (estimated)
Results: Posted 31 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Group A	Experimental	Drug: PegfilgrastimAll eligible patients will receive chemotherapy and one dose of Pegfilgrastim

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PegfilgrastimAlso: NeulastaPegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy).	Drug	Group A

Primary outcome

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.

1 secondary outcome

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.

Results and safety

Results posted to the registry on 31 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chemotherapy Plus Pegfilgrastim	7	7

Primary outcome: 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

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

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chemotherapy Plus Pegfilgrastim	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hematologic Malignancies

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John M Hill Jr., MD principal investigator

Dartmouth-Hitchcock Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pegfilgrastim in people with Hematologic Malignancies, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00689884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.