Hematologic Malignancies
Conditions
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.
Interventions
DRUGPegfilgrastim
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).
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg | 2 years | Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy Plus Pegfilgrastim All eligible patients will receive chemotherapy and one dose of Pegfilgrastim | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Chemotherapy Plus Pegfilgrastim |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 22 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 2 years
Population: Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
Secondary
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).
Time frame: At each stage of pheresis for each enrolled subject for a maximum of 2 years.
Population: Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.