Comparative efficacy of reduced or standard doses of lenograstim for peripheral blood stem cell mobilization and transplantation: A randomized study in patients undergoing autologous peripheral stem cell transplantation

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7099-7099
Author(s):  
M. Ozturk ◽  
F. Arpaci ◽  
S. Ataergin ◽  
A. Ozet ◽  
T. Cetin ◽  
...  
Keyword(s):  
Stem Cell ◽  
Peripheral Blood ◽  
Dose Group ◽  
Low Dose ◽  
Peripheral Blood Stem Cell ◽  
Standard Dose ◽  
Randomized Study ◽  
Median Number ◽  
Cd34 Cells ◽  
Pbsc Mobilization

7099 Background: 10 microg/kg/day of filgrastim and lenograstim have been recommended for mobilization of CD34+ cells without associated chemotherapy. However,in our previous randomized study we demonstrated that a 7.5 microg/kg/day dose of lenograstim has been as efficacious as 10 microg/kg/day of filgrastim. In this study, we investigated whether a reduced dose of lenograstim is equavalent to standard dose for autologous peripheral blood stem cell (PBSC) mobilization and transplantation. Methods: A total of 49 consecutive patients were randomized to either low dose (7.5 microg/kg/day, n = 24) or standard dose (10 microg/kg/day, n = 25) of lenograstim. These two groups were similar in regard to disease, sex, body weight, body surface area, conditioning regimens, previous chemotherapy cycles and radiotherapy. Each dose of lenograstim was administered for 4 consecutive days. The first PBSC apheresis was done on the 5th day. In the posttransplant period, lenograstim was given at 5 microg/kg/day until leukocyte engraftment. Results: Successful mobilization with the first apheresis, was achieved in 10/24 (42%) patients in low dose group versus 14/25 (56%) patients in standard dose group. No significant difference was seen in the median number of CD34+cells mobilized, as well as the median number of apheresis, median volume of apheresis, percentage of CD34+ cells, and CD34+ cell number. Leukocyte and platelet engraftments, the number of days requiring G-CSF and parenteral antibiotics, the number of transfusions were similar in both groups in the posttransplant period. Conclusions: Lenograstim 7.5 microg/kg/day is as efficious as Lenograstim 10 microg/kg/day for autologous PBSC mobilization and transplantation. No significant financial relationships to disclose.

Impact of Rituximab on Peripheral Blood Stem Cell Mobilization and Collection Following ACVBP Regimen in Poor Risk Patients with Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Large Cohort of Patients from Two Prospective GELA Trials.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2314-2314
Author(s):  
Francois Lefrere ◽  
Dominique bastit-Barrau ◽  
Suzanne Mathieu ◽  
Alain Bohbot ◽  
Philippe Bourrin ◽  
...  
Keyword(s):  
Stem Cell ◽  
Peripheral Blood ◽  
Peripheral Blood Stem Cell ◽  
B Cell Lymphoma ◽  
Median Number ◽  
Blood Stem Cell ◽  
Poor Risk ◽  
Cd34 Cells ◽  
Risk Patients ◽  
Pbsc Mobilization

Abstract <>The ACVBP regimen is commonly used in young poor-risk patients with DLBCL candidates to first line consolidative high-dose therapy followed by autologous stem cells transplantation in GELA trials. The combination with the monoclonal anti-CD20 antibody rituximab (R-ACVBP) is now routinely used, as induction treatment and to mobilize peripheral blood stem cell (PBSC). The aim of the present study was to assess the impact of rituximab on PBSC mobilization and collection in patients with newly diagnosed DLBCL receiving ACVBP chemotherapy. We reviewed the data from two prospective controlled trials. The first, conducted between 1999 and 2003, involved patients presenting with 2 or 3 adverse prognostic factors on the basis of the age-adjusted IPI (aa-IPI), treated by ACVBP (LNH 98B-3) (ASCO2007:8018). In the second trial (LNH 03-3B), conducted between 2004 and 2007, similar patients received the same initial inductive chemotherapy combined to rituximab (375mg/m2 at D1). 137 and 91 patients in the ACVBP and the R-ACVBP groups are here analyzed, respectively. Clinical and biological characteristics at diagnosis of the two groups of patients were similar (aa-IPI 2 and aa-IPI 3: 75% and 25%, respectively). The conditions for G-CSF administration and stem cell collections were identical. PBSC mobilizations were performed following the third or fourth cycle of (R)-ACVBP. The median delay between day 1 of chemotherapy and the first hemapheresis was identical for both groups. First hemapheresis was performed with a median peripheral white blood cell concentration of 16.2 x 109/l and 16.6 x 109/l for ACVBP and R-ACVBP groups, respectively. The median peak number of peripheral blood CD34+ cells observed the same day of first hemapheresis in ACVBP and R-ACVBP group was 69 x 106/l and 63 x 106/l, respectively (p = 0.5). The median number of CD34+ cells collected were 7.1 x 106 and 6.0 x 106 CD34 cells/kg for ACVBP and R-ACVBP groups (p = 0.12) while the median number of hemapheresis to target a minimal number of 3 x 106 CD34 cells/kg was identical, of one, in both groups. Failure of stem cell collection , defined as less than 3 x 106 CD34 cells/kg harvested, was observed in 8% and 4% of the patients who received ACVBP or R-ACVBP , respectively (p = 0.13). We conclude that rituximab combined to ACVBP regimen does not impair PBSC mobilization and collection.

Bendamustine (Treanda®), Etoposide and Dexamethasone (BED) Followed by GCSF Effectively Mobilizes Autologous Peripheral Blood Hematopoietic Stem Cells

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4126-4126
Author(s):  
Damian J. Green ◽  
William I. Bensinger ◽  
Leona Holmberg ◽  
Theodore A. Gooley ◽  
Brian G. Till ◽  
...  
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
B Cell ◽  
Peripheral Blood ◽  
Research Funding ◽  
Median Number ◽  
Cross Resistance ◽  
Cd34 Cells ◽  
Predictable Pattern ◽  
Pbsc Mobilization

Abstract Abstract 4126 Background: High dose chemotherapy followed by autologous stem cell transplantation (ASCT) is a standard of care for patients with advanced or treatment refractory multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Stem cell proliferation and mobilization can be enhanced though the addition of myelosuppressive chemotherapy to GCSF administration. Chemotherapeutic agents without cross resistance to prior therapies may support peripheral blood stem cell (PBSC) collection and improve patient outcomes by exacting a more potent direct anti-tumor effect prior to ASCT. Bendamustine (Treanda®) is a synthetic chemotherapeutic agent that shares structural similarities to both purine analog and alkylating agents without significant cross resistance to other compounds in either drug class. Bendamustine appears to have low stem cell toxicity in vitro, is well tolerated, and has activity in MM and NHL. We hypothesized that bendamustine's activity in patients with disease resistant to first line therapies makes it a logical candidate for chemotherapy based PBSC mobilization. Methods: Patients were eligible if they had relapsed or refractory MM, B-cell NHL or T-cell NHL and were candidates for ASCT. Other criteria included: age >18 years, ANC >1,500/mm3, platelets >100,000/mm3, adequate renal and hepatic function, <3 prior myelotoxic regimens, <6 cycles of lenalidomide, no prior failed mobilization attempt, and no prior pelvic/spinal irradiation. Patients received 1 cycle of BED therapy [bendamustine (120 mg/m2 IV d 1, 2 - provided along with financial support for this study by Teva Pharmaceuticals), etoposide (200 mg/m2 IV d 1– 3), dexamethasone (40 mg PO d 1– 4), delivered as an outpatient, followed by filgrastim (10 mcg/kg/day; starting on d 5 through end of collection)]. Apheresis was initiated when peripheral blood CD34 cell counts were >5/μL. The primary endpoint was successful mobilization, defined as collection of >2.0 × 106CD34 cells/kg. Adverse events (AEs) were graded using the CTCAE v4.0. Results: Twenty patients (16 MM, 3 B-cell NHL, 1 NK/T-cell NHL) were treated. The median age was 59 years (range 43–70), and the median number of prior therapies was 1 (range 1–3) for MM and 2 (range 2–3) for NHL patients. All patients (20/20) were successfully mobilized. The median number of CD34+ cells collected was 19.11 × 106/kg (Mean 22.49; range 4.35 to 55.51 × 106). All MM patients collected >10 × 106 CD34+cells/kg. The median time from BED mobilization therapy to the first day of CD34 stem cell collection was 12 days (mean 12.05; range 10 to 20 days). The median number of days of apheresis was 1 (mean 1.45; range 1 to 4). A predictable pattern of leucocyte nadir and recovery was demonstrated (88% of patients started apheresis between days 10–12). One patient (5%) was given plerixafor and for 2 patients (10%) the dose of GCSF was increased to 16 mcg/kg twice daily. Among the 20 patients mobilized and collected, 12 have thus far undergone ASCT and 100% (12/12) have achieved an unsupported neutrophil count >500/μL at an average of 14.3 days after PBSC infusion and a platelet count >20K/μL at an average of 10 days. Serious AEs (SAEs) were observed in 5 patients and 1 patient died due to disease progression. No unexpected grade 3 or greater treatment related SAEs were seen. Disease response assessments are ongoing. The original protocol design involved 3 agents (bendamustine, dexamethasone and GCSF [BDG]). After the first 3 patients enrolled, the mobilization regimen was modified to include etoposide because BDG did not yield a predictable pattern of leucocyte nadir and recovery, thus complicating timing for apheresis (median time to collection 22 days). The first 3 patients were censored from the analysis, however all 3 patients were successfully mobilized and collected. Conclusions: The initial experience with PBSC mobilization after BED in this phase II study suggests the regimen is safe and effective, while the use of BDG does not yield predictable CD34 kinetics. Time to neutrophil and platelet engraftment after ASCT appears unimpaired when compared with other chemotherapy based mobilization regimens. Large numbers of stem cells were rapidly mobilized and resulted in short durations of apheresis. No patient with MM collected <10 × 106 CD34+ cells/kg (sufficient for 2 ASCTs). The regimen was very well tolerated and these findings suggest that the role of bendamustine in PBSC mobilization should be further explored. Disclosures: Green: Teva Pharmaceuticals: Research Funding. Holmberg:Millenium: Research Funding; Otsuka: Research Funding; Merck: Research Funding; Seattle Genetics: Research Funding; Sanofi: Research Funding. Budde:Teva Pharmaceuticals: Research Funding. Gopal:Teva Pharmaceuticals: Research Funding.

Brentuximab Vedotin (BV) Does Not Impair Autologous Peripheral Blood Stem Cell Mobilization and Collection in Refractory/Relapsed CD30+ Lymphoma Patients Undergoing High-Dose Chemotherapy and Autologous Stem Cell Transplant (HDC-ASCT)

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3854-3854
Author(s):  
Manuel Afable ◽  
Paolo F. Caimi ◽  
Chitra Hosing ◽  
Marcos de Lima ◽  
Issa F. Khouri ◽  
...  
Keyword(s):  
Stem Cell ◽  
Hodgkin Lymphoma ◽  
Median Time ◽  
Peripheral Blood ◽  
Peripheral Blood Stem Cell ◽  
Median Number ◽  
Brentuximab Vedotin ◽  
Cd34 Cells ◽  
Cell Mobilization ◽  
Stem Cell Collection

Abstract Introduction. Salvage chemotherapy followed by HDC-ASCT is considered standard of care for chemosensitive patients who have relapsed after initial therapy. CD30 is commonly expressed in Hodgkin Lymphoma (HL) and in some cases of non-Hodgkin lymphoma (NHL). Brentuximab vedotin (BV), an antibody-drug conjugate that targets CD30, induces high response rates and is now used in the salvage setting prior to HDC-ASCT. It is not clear if BV use peri-mobilization would influence mobilization and collection of autologous CD34+ stem cells. We therefore examined 42 patients who were treated with BV prior to HDC-ASCT. Methods. We retrospectively reviewed the HDC-ASCT databases of University Hospitals Case Medical Center (UHCMC) and MD Anderson Cancer Center (MDACC) and identified 42 patients who were treated with BV prior to HDC-ASCT between February 2009 and April 2014. The median age was 37 years (range, 18-67) and 52% (n=22) were male. Diagnoses were HL (n=30; 71%;), and NHL (n=12; 29%; anaplastic large cell, n=6; diffuse large B-cell, n=3; unknown subtype, n=3). Median times from diagnosis to transplant, from initial BV treatment to transplant and from last BV treatment to stem cell collection were: 21 months (range, 10-210), 5 months (range, 1.5-16.8), and 30 days (range, 2-280), respectively. Our subjects had failed multiple conventional treatments with a median of 3 (range, 2–8) lines of treatment before HDC-ASCT; 38% (n=16) received involved field radiation therapy. BV was given at 1.8 mg/kg IV every 21 days. Median number of BV cycles was 4 (range, 1-16) and the overall response rate to treatment was 71% (CR 55% + PR 16%). Thirty patients (71%) were in complete remission (CR) at the time of transplant (CR2 = 6; CR≥3 = 24), 4 (10%) were in partial remission (PR) (PR2 = 1; PR≥3 = 3), 6 patients (14%) had stable disease and 2 patients (5%) were transplanted with progressive disease. Stem cell collection target was 5 x 106 CD34+ cells/Kg. Mobilization regimens used were chemotherapy/G-CSF-based in 32 patients (76%) and Plerixafor/G-CSF-based in 10 patients (24%). Use of chemotherapy/G-CSF in first mobilization was standard at MDACC, whereas plerixafor/G-CSF was used as first mobilization at UHCMC. Results. Thirty-nine (92.8%) of 42 patients were successfully mobilized on the first attempt. Second mobilization was required in 3 cases (7.1%). Second mobilization regimens included Cyclophosphamide/G-CSF (n=2) and Plerixafor/G-CSF (n=1). The median number of infused CD34+ cells was 5.46 x106/kg (range, 1.65-54.78 x106/kg). All patients engrafted neutrophils and platelets at a median time of 10 days (range, 9-13), and 10.5 days (range, 7-35), respectively. The median time to RBC transfusion independence was 8 days (0-34). With a median follow-up of 12 months (range, 0–63), day 100 treatment-related mortality was 0%. The one-year actuarial event-free and overall survival is 50.5% and 84.1%, respectively. Conclusion. Within the limitations of this retrospective study, BV before HDC-ASCT did not adversely affect peripheral blood stem cell mobilization, collection and engraftment in a cohort of heavily pre-treated, relapsed/refractory patients with CD30+ lymphomas. Disclosures Caimi: Seattle Genetics: Equity Ownership.

Evaluating the Clinical Efficacy of Increased Granulocyte Colony-Stimulation Factor (GCSF) in Patients Who Fail a Standard Dose Regimen during Peripheral Blood Stem Cell Collection.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2926-2926
Author(s):  
Shirong Wang ◽  
Nademanee Auayporn ◽  
Park Hyun Soon ◽  
Joy Fridey ◽  
Jocelynne Palmer ◽  
...  
Keyword(s):  
Stem Cell ◽  
Clinical Efficacy ◽  
Peripheral Blood ◽  
Dose Regimen ◽  
Peripheral Blood Stem Cell ◽  
Standard Dose ◽  
Total Yield ◽  
Case Series ◽  
Median Number ◽  
Blood Stem Cell

Abstract Granulocyte Colony-Stimulating Factor (GCSF) at 10 microg/kg (with or without chemotherapy) is the standard dose commonly administered to patients undergoing Peripheral Blood Stem Cell (PBSC) mobilization and collection. Due to various host and disease factors, 10–20% of our patients failed to mobilize sufficient PBSC at this standard dose. At our institution it is common practice to increase GCSF from 10 microg/kg to 16–20 microg/kg during the initial or second mobilization attempt if the patient is able to tolerate the increased dose. To assess the clinical efficacy of increased GCSF administration among patients who fail to mobilize at the standard dose, we performed a retrospective chart review of 112 patients who underwent stem cell mobilization and collection between 01/31/2000 and 11/6/2003. The median age at the start of collection was 51.2 (range: 1.3–72.2); the case-series was made up of 52 men and 60 women. The majority of the cases were Lymphoma patients (Non-Hodgkin’s Lymphoma=52; Hodgkins Disease=15) with the remaining patients classified as Acute Myeloid Leukemia (AML=12), Multiple Myeloma (MM=13), or ‘Other’ (N=20). Initially all 112 patients received 4–10 days of GCSF at 10 microg/kg per day before the first day of PBSC collection. Because these patients failed to collect sufficient daily CD34 cells, the GCSF dose was increased to 16–20 microg/kg. Before increasing the GCSF dose, the median CD34 daily yield was 0.19 (range: 0.03–0.90), and the median peripheral WBC was 27.6 (range: 1.3–61.8). The median number of collection at 10 microg/kg was 4 (range 2–15), and the median number of days from the end of collection at 10 microg/kg to the start of 16–20 microg/kg was 1 (range: 0–53). After increasing the GCSF dose the median peripheral WBC was 37.1 (range: 3.1–70.2), and the median CD34 daily yield was 0.28 (range: 0.03–3.43). The median CD34 total yield was 3.1 (range 0.6–12.3). Ultimately 90 patients (80%) reached a CD34 cell target of 2*10–6/kg (range: 2.0–12.3), and 22 patients (20%) did not reach this target. The overall difference in CD34 counts pre-post increased GCSF administration was statistically significant (Wilcoxon p<0.01). The difference in CD34 counts (pre-post increase GCSF dose) was explained by age only; the patient’s diagnosis and gender had no statistically significant explanatory value. Patients less than 40 years of age were more likely to have successful PBSC collection with an increase dose of GCSF (p=0.02). The mean difference in daily CD34 yield for patients <40 years was 0.38; for patients ≥40 years was 0.11. Based on this analysis we recommend to increase GCSF dose to 16microg to 20 microgram/kg among the younger (<40 years) patients who failed a standard dose regimen at 10microg/kg, while other re-mobilization regimens should be considered for older patients irrespective of their gender or underlying diagnosis.

scholarly journals Impact of the Use of Bendamustine Immediately before the Collection of Hematopoietic Stem Cells in Lymphoma. a Study By the Geltamo Group

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1771-1771
Author(s):  
Mariana Bastos-Oreiro ◽  
Javier Anguita ◽  
José Fernández ◽  
Ana Pilar Gonzalez ◽  
Raul Córdoba ◽  
...  
Keyword(s):  
Stem Cell ◽  
Peripheral Blood ◽  
Research Funding ◽  
Median Number ◽  
Control Group ◽  
First Line ◽  
Hematopoietic Stem ◽  
Cd34 Cells ◽  
Number Of Cycles ◽  
Pbsc Mobilization

Abstract Introduction: Bendamustine is a hybrid alkylating agent with high efficacy in different haematological malignancies, especially for lymphomas. Data about the capacity of peripheral blood stem cell (PBSC) mobilization or a possible stem cell toxicity after the use of bendamustine are unclear, with sufficient number of PBSC after bendamustine- rituximab (B-R) combination used in first line but with scarce information in relapse, especially with the use of bendamustine immediately before mobilization. The aim of this study was to evaluate the influence on PBSC mobilization of bendamustine as the last previous regimen used before the collection of PBSC. Methods: This is a retrospective, multicentre study, which includes patients from 8 different GELTAMO centres in Spain. Forty-eight lymphoma patients who received bendamustine followed immediately by stem cell mobilization (SCM) were included. A single-centre control group of consecutive patients was included, matched by histology, age and number of previous lines; HIV+ patients were excluded. Results: We included 83 patients, 45 in the bendamustine group and 38 in the control group. Table 1 shows patient´s characteristics. Both groups are adequately balanced. No patients received previous lenalidomide, and none patient had previous transplant. In the bendamustine group, the median number of cycles administered was 4 (range 2-6). In 8 patients of the bendamustine group and 12 in the control group the mobilization was programmed after first-line treatment. In the remaining cases, mobilizations were performed after 1 st or 2 nd relapse treatment. In most of the patients, the mobilization regimen was performed only with G-CSF, although 7 patients in the control and 3 patients in bendamustine groups received alternative regimens such as ESHAP, DHAP or ICE. Ten patients in the bendamustine group received plerixafor as part of the 1 st attempt mobilization regimen. Median number of apheresis with the first attempt of mobilization was 1.5 in the bendamustine group vs 1.3 in the control group. In bendamustine group 8 patients didn't go to apheresis due to a low pre-mobilization CD34+ cell count in peripheral blood, compared with 2 patients in control group. Median pre-mobilization CD34+ cells and median number of mobilized CD34 cells obtained was significative lower with in bendamustine group (Table 1). Moreover, 10 patients in this group didn't mobilized with 1 st attempt (and in 4 of them and neither with the second mobilization attempt), compared with only 2 in the control group. Mobilization failure in the bendamustine group was more frequent in certain lymphoma subtypes (among the 10 failures, HL and FL were the most frequent, 40%, p=0.07, and 50%, p=0.051 respectively), and was also associated with number of previous lines of therapy (HR 4,1; p= 0.041), since 90% of the failures were patients mobilized at relapse, and only 1 as 1st line consolidation. No relationship was found between stage, doses, or number of cycles of bendamustine administered. Conclusion: Our results show that the collection of sufficient numbers of PBSC could be affected by the use of bendamustine immediately prior to mobilization, especially in more pre-treated patients. We continue working on expanding our series to confirm these results. Figure 1 Figure 1. Disclosures Bastos-Oreiro: Kite: Speakers Bureau; Gilead: Honoraria; BMS-Celgene: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; F. Hoffmann-La Roche: Honoraria, Research Funding, Speakers Bureau; Takeda: Speakers Bureau; Novartis: Honoraria, Speakers Bureau. Salar: Roche: Consultancy, Speakers Bureau; Gilead: Research Funding; Janssen: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau. Sancho: Roche, Janssen, Celgene-BMS, Gilead, Novartis, Takeda: Honoraria, Speakers Bureau; Roche, Janssen, Celgene-BMS, Gilead, Novartis, Incyte, Beigene: Speakers Bureau.

Bendamustine (Treanda®)-Based Regimens Are Effective In Mobilizing Peripheral Blood Hematopoietic Stem Cells For Autologous Transplantation

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2033-2033
Author(s):  
Damian J. Green ◽  
William I. Bensinger ◽  
Leona Holmberg ◽  
Theodore A. Gooley ◽  
Brian G. Till ◽  
...  
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
T Cell ◽  
Disease Progression ◽  
Peripheral Blood ◽  
Median Number ◽  
Cross Resistance ◽  
Single Cycle ◽  
Cd34 Cells ◽  
Pbsc Mobilization

Abstract Background High dose chemotherapy followed by autologous stem cell transplantation (ASCT) is a standard of care for patients with advanced or treatment refractory multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Stem cell proliferation and mobilization can be enhanced though the addition of myelosuppressive chemotherapy prior to GCSF administration. Chemotherapeutic agents without cross resistance to prior therapies may support peripheral blood stem cell (PBSC) collection and improve patient outcomes by exacting a more potent direct anti-tumor effect prior to ASCT. Bendamustine (Treanda®) is a synthetic chemotherapeutic agent that shares structural similarities to both purine analog and alkylating agents without significant cross resistance to other compounds in either drug class. Bendamustine appears to have low stem cell toxicity in vitro, is well tolerated, and has activity in MM and NHL, but the potential for the purine moiety to adversely impact stem cell reserve is unknown. We hypothesized that bendamustine’s activity in patients with disease resistant to first line therapies makes it a logical candidate for chemotherapy based PBSC mobilization and tested its impact on stem cell yield. Methods Patients were eligible if they had relapsed or refractory MM, B-cell NHL or T-cell NHL and were candidates for ASCT. Other criteria included: age >18 years, ANC >1,500/mm3, platelets >100,000/mm3, adequate renal and hepatic function, <3 prior myelotoxic regimens, <6 cycles of lenalidomide, no failed mobilization attempt, and no prior pelvic/spinal irradiation. Patients received 1 cycle of BED therapy [bendamustine (120 mg/m2 IV d 1, 2 - provided along with financial support for this study by Teva Pharmaceuticals), etoposide (200 mg/m2 IV d 1- 3), dexamethasone (40 mg PO d 1- 4), delivered as an outpatient, followed by filgrastim (initially 10 mcg/kg/d sc; starting on d 5 through end of collection)]. Apheresis was initiated when peripheral blood CD34 cell counts were >5/µL. The primary endpoint was successful mobilization, defined as collection of >2.0 x 106CD34 cells/kg. AEs were graded using the CTCAE v4.0. Results Thirty-seven patients (32 MM, 4B-cell NHL, 1 NK/T-cell NHL) were treated. The median age was 60 years (range 43-70). The median number of prior therapies was 1 (range 1-3) for MM and 2 (range 1-3) for NHL patients. All patients (37/37) were successfully mobilized. The median number of CD34+ cells collected was 19.43 x 106/kg (range 4.35 to 55.51 x 106). All MM patients collected >10 x 106 CD34+cells/kg. The median time from the start of BED mobilization therapy to the first day of CD34 stem cell collection was 12 days (range 9 to 20 days). The median number of apheresis days was 1 (range 1 to 4). A predictable pattern of leucocyte nadir and recovery was demonstrated (95% of patients started apheresis between days 9-13). Two patients (5%) were given plerixafor and for 2 patients (5%) GCSF was increased to 16 mcg/kg twice daily. Among the 37 patients mobilized and collected, 31 have thus far undergone ASCT and 100% (31/31) achieved an unsupported neutrophil count >500/µL at a median of 15 days (range 7-19) after PBSC infusion and a platelet count >20K/µL at a median of 11 days (range 8-14). Ten SAEs were observed in 8 patients and 1 patient died due to disease progression prior to ASCT. SAEs include: neutropenic fever (1, grade [GR] 3), bone pain (2, GR 3), renal insufficiency (1, GR 1), atrial fibrillation (1, GR 2), hypotension (1, GR 3), stroke (1, GR 2), and one patient accounted for 3 SAEs including GR 3 tumor lysis syndrome and sepsis and GR 5 disease progression. Among twenty-nine evaluable patients to date, responses include: CR= 4 PR=2, SD=19 and PD=4. The ORR to this single cycle of therapy was 21%. Conclusions PBSC mobilization with BED is safe and effective. BED is not an acute stem cell toxin. Large numbers of stem cells were rapidly mobilized and resulted in short durations of apheresis. No patient with MM collected <10 x 106 CD34+ cells/kg (sufficient for 2 ASCTs). Twenty-one percent of patients demonstrated a measurable response to a single cycle of BED therapy and an additional 65% of patients had stable disease. In patients who were transplanted, the time to neutrophil and platelet engraftment was comparable to other chemotherapy based mobilization regimens. The BED regimen was well tolerated and these findings suggest that the role of BED in PBSC mobilization should be further explored. Disclosures: No relevant conflicts of interest to declare.

Decision-Tree Algorithm Optimize Hematopoietic Progenitor Cell-Based Prediction in Peripheral Blood Stem Cell Mobilization

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1903-1903
Author(s):  
Chia-Yun Wu ◽  
Tzeon-Jye Chiou ◽  
Chun-Yu Liu ◽  
Feng-Chang Lin ◽  
Jeong-Shi Lin ◽  
...  
Keyword(s):  
Risk Factors ◽  
Stem Cell ◽  
Decision Tree ◽  
Peripheral Blood ◽  
Peripheral Blood Stem Cell ◽  
Decision Tree Algorithm ◽  
Hematopoietic Progenitor ◽  
Cart Analysis ◽  
Cd34 Cells ◽  
Pbsc Mobilization

Abstract Background and Objectives Enumeration of hematopoietic progenitor cells (HPC) using an automated hematology analyzer provides rapid, inexpensive, and less technically dependent prediction of peripheral blood stem cell (PBSC) mobilization. This study aimed to incorporate HPC enumeration along with other predictors for optimizing a successful harvest. Materials and Methods Between 2007 and 2012, 189 consecutive patients who proceeded to PBSC harvesting with a preharvest HPC ≥ 20 x 106 /L were recruited. A failed PBSC mobilization was defined as < 2 x 106 CD34+ cells/kg. Variables predicting a successful harvest identified by multivariate logistic regression and correlation analysis were subjected to classification and regression tree (CART) analysis. Results A total of 154 (81.5%) patients successfully achieved mobilization of CD34+ cells (median 8.18 x 106 CD34+ cells/kg). Five independent host predictors including age ≥ 60, a diagnosis of solid tumor, prior chemotherapy cycles ≥ 5, prior radiotherapy, and mobilization with G-CSF alone or high-dose cyclophosphamide, as well as laboratory markers including HPC and mononuclear cell (MNC) counts, were used for CART analysis. The number of host predictors with a cutoff at two, HPC cutoff at 28 x 106/L and MNC cutoff at 3.5 x 109 /L were best discriminative for successful prediction. In the decision tree algorithm, patients predicted as good mobilizers (0 to 2 risk factors) had a higher success rate (150/169, 88.8%) than that (4/20, 20.0%) of those predicted as poor mobilizers (3-5 risk factors). Moreover, patients predicted as good mobilizers and further with a HPC enumeration ≥ 28 x 106/L had a high probability of achieving successful mobilization (138/148, 93.2%). Conclusion Our CART algorithm incorporating host predictors, HPC enumeration and MNC count may improve prediction and thus increase the success of PBSC mobilization. Further prospective validation is necessary. Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.

scholarly journals Platelet Decrease and Efficacy of Platelet-Rich Plasma Return for Peripheral Blood Stem Cell Apheresis

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 29-30
Author(s):  
Takahiro Shima ◽  
Teppei Sakoda ◽  
Tomoko Henzan ◽  
Yuya Kunisaki ◽  
Takahiro Maeda ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Stem Cell ◽  
Platelet Count ◽  
Peripheral Blood ◽  
Peripheral Blood Stem Cell ◽  
Platelet Rich Plasma ◽  
Blood Stem Cell ◽  
Platelet Recovery ◽  
Platelet Counts ◽  
Cd34 Cells

Peripheral blood stem cell (PBSC) transplantation is a key treatment option for hematological diseases and widely performed in clinical practice. Platelet loss is the major complication of PBSC apheresis, and platelet-rich plasma (PRP) return is recommended in case of severe platelet decrease following apheresis; however, little is known about the frequency and severity of platelet loss nor the efficacy of PRP return post-apheresis. To address these questions, we assessed changes in platelet counts following PBSC-related apheresis in 270 allogeneic (allo)- and 105 autologous (auto)-PBSC settings. We also evaluated efficacy of PRP transfusion on platelet recovery post-apheresis. Platelet counts reduced up to 70% post-apheresis in both allo- and auto-PBSC settings, while severe platelet count decrease (&lt; 50 x 109/L) was only observed in auto-PBSC patients (Figure 1). We next analyzed the relationship between severe platelet (&lt; 50 x 109/L) after apheresis and several clinical factors by using univariate and multivariate analysis for auto-PBSC patients. As shown in Table 1, in univariate analysis, severe platelet counts following auto-PBSC apheresis was found more frequently in patients with lower platelet count, lower percentage of CD34+ cells in PB at pre-apheresis, repeated round of apheresis, and smaller number of collected CD34+ cells. On the other hand, in multivariate analysis, the white blood cell (WBC) counts pre-apheresis was the only significant risk factor of severe platelet count following apheresis (p = 0.038). We finally analyzed the transitions of platelet counts in the setting of apheresis. The median platelet counts at pre-apheresis, post-apheresis, and post-PRP return were 187.0 x 109/L, 132.0 x 109/L, and 154.0 x 109/L for allo-PBSC apheresis, and 147.0 x 109/L, 111.0 x 109/L, and 127.0 x 109/L for auto-PBSC apheresis (p &lt; 0.0001 for all, allo-PBSC donors and auto-PBSC patients, respectively) (Figure 2), indicating that PRP return post-apheresis facilitated a rapid platelet recovery in both allo- and auto-settings. Collectively, our data suggest that WBC counts pre-apheresis is a useful predictor for severe platelet decrease following auto-PBSC apheresis and that PRP return is an effective mean to facilitate platelet recovery post-apheresis. Disclosures No relevant conflicts of interest to declare.

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