Status:
TERMINATED
Feasibility and Cost Analysis of PBSC Mobilization Using Pegfilgrastim in Hematologic Malignancies
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00689884
Start Date
January 1 2007
End Date
January 1 2009
Last Update
April 20 2018
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756