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CompletedNCT01696461Updated Sep 14, 2023Results posted

A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor

A Phase 2 interventional study of Plerixafor in Related Donors Donating Peripheral Blood Stem Cells (PBSC) to a Family Member, Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia, sponsored by Center for International Blood and Marrow Transplant Research. Completed at 12 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Center for International Blood and Marrow Transplant Research · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
127
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.

Read the detailed description

The primary objective is to determine the proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.

All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.Recipients will be classified into one of the two strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.

02

Conditions studied

  • Related Donors Donating Peripheral Blood Stem Cells (PBSC) to a Family Member
  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • Chronic Myelogenous Leukemia
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Chronic Lymphocytic Leukemia
03

In context

Leukemia, Myeloid, Acute

3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.

This study's enrollment of 127 is above the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Center for International Blood and Marrow Transplant Research is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Donor:

  • Donor eligibility will be determined according to applicable federal, state and local regulations and institutional standards
  • 18-65 years of age
  • 6/6 HLA-matched sibling
  • Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor
  • Serum creatinine \<2.0mg/dl

Recipient:

  • 18 to 65 years of age
  • 6/6 HLA antigen matched sibling willing to donate PBSC for transplant
  • Fulfill individual Transplant Center Criteria for transplant

  • One of the following diagnoses:

    • Acute myelogenous leukemia (AML) in 1st remission or beyond with \<5% marrow blasts and no circulating blasts. Marrow must be done within 30 days of the start of transplant conditioning regimen in alignment with other pre-transplant assessments.
    • Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with \<5% marrow blasts and no circulating blasts
    • Myelodysplastic syndrome, either intermediate-1,2, or high risk by International Prognostic Scoring System or transfusion dependent
    • Chronic myelogenous leukemia (CML) failing or intolerant to tyrosine kinase inhibitor based therapy
    • Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission, or in relapse (but with at least stable disease after most recent therapy)
    • Chronic lymphocytic leukemia (CLL), relapsing after at least one prior regimen, or in remission with 17p deletion
  • Serum creatinine must be \<2.0mg/dl
  • Total bilirubin and aspartate aminotransferase (AST) \<3x normal
  • Infectious disease marker (IDM) monitoring will be performed per institutional standards
  • Karnofsky performance status of 70% or greater.
  • Patients who have undergone a prior autologous transplantation are eligible for a reduced intensity transplant only

Exclusion criteria

Exclusion Criteria:

Donor:

  • Donor unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
  • Donor already enrolled on another investigational agent study
  • Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active

Recipient:

  • Patient unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
  • Patients with active, uncontrolled infection at the time of the transplant preparative regimen
  • Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active
  • Patients with a history of previous central nervous system (CNS) tumor involvement showing active symptoms or signs along with documented disease on lumbar puncture and MRI of the brain within 30 days of start of conditioning
  • A condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of primary and secondary endpoints.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    Related donors receiving plerixafor

    Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent. Eligible donors determined according to institutional standards * 18-65 years of age * 6/6 HLA-matched sibling * Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor * Serum creatinine \<1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CLCR) \>50 mL/min Treatment Description: * Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later. * Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is \> 4.0 x 106/kg with a minimum of \> 2.0 x 106/kg.

    Drug: Plerixafor

  • No intervention
    Recipients, myeloablative regimen

    Patients undergoing conditioning under a myeloablative regimen Myeloablative (one of four general regimens): Busulfan (\> 9 mg/kg po or iv total) with fludarabine Busulfan (\> 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (\> 1000 cGy) plus etoposide Total body irradiation (\> 500 cGy) plus cyclophosphamide

  • No intervention
    Recipients, reduced intensity conditioning regimen.

    Patients undergoing conditioning using a reduced intensity conditioning regimen. Reduced Intensity (one of three general regimens): Busulfan (\< 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (\> 2000 mg/m2 total)

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.

    Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.

    Time frame: donation

Secondary outcomes

  1. Incidence and Severity of Acute Toxicities

    Incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor. Acute toxicities are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Grade of maximum toxicity across all time points is reported. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.

    Time frame: baseline, Day 1, Day 2, Day 3

  2. Adverse Effects

    Adverse effects experienced by donors receiving plerixafor up to one year post donation. Number of participants with a maximum MTC \>0 reported at each individual time point. Adverse effects are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Participants can experience adverse effects at more than one time point evaluated. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.

    Time frame: 30 minutes, 60 minutes, 120 minutes, 240 minutes, 1 month, 6 months, 12 months post donation for each subject

  3. Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

    Incidence of and kinetics of neutrophil and platelet recovery by day 100 in recipients after transplantation of hematopoietic cells mobilized with plerixafor.

    Time frame: Day +1 through neutrophil recovery or Day 21 (whichever is first)

  4. T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

    T-cell (CD3+) and myeloid (CD33+) chimerism in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.

    Time frame: Chimerism was evaluated at serial timepoints post HCT in patients in both RIC and MAC strata. Chimerism was assessed at Day +28, +100, +180, and +365

  5. Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

    Incidence of primary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.

    Time frame: Day 28

  6. Incidence of Acute Graft-versus-host Disease (GVHD)

    Incidence of acute graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor

    Time frame: Day 100

  7. Immune Reconstitution

    Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor.

    Time frame: Day 28, 100, 180, 365

  8. Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.

    Percentage of recipients with prior CMV infection whose CMV was reactivated after transplantation with cell mobilized with plerixafor

    Time frame: day 365

  9. Treatment-related Mortality and Disease Relapse/Progression

    Incidence of treatment-related mortality and disease relapse/progression in recipients after transplantation of hematopoietic cells mobilized with plerixafor

    Time frame: Day 180, 365

  10. Progression-free and Overall Survival

    Probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor

    Time frame: Day 180, 365

  11. Cellular Composition of Allografts

    Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells)

    Time frame: donation

  12. Incidence of Chronic Graft-versus-host Disease (GVHD)

    Incidence of chronic graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor

    Time frame: Day 365

  13. Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

    Incidence of secondary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.

    Time frame: Day 365

  14. CD34+ Cell Count of Allografts

    CD34+ cell count of allografts mobilized with plerixafor

    Time frame: donation

07

Results

Posted Sep 14, 2023
Limitations and caveats
Although this was a prospective multicenter trial, conclusions are limited by the single arm design and small sample size.

Participant flow

Eligible donor-recipient pairs were recruited at 12 US hematopoietic cell transplantation (HCT) transplant centers between July 2013 and December 2014. Recipients who met eligibility criteria provided written informed consent prior to any study procedure being performed. In order for the recipient to proceed in the study, intended donors were required to consent as well.

Participant flow — Overall Study
MilestoneRelated Donors Receiving PlerixaforRecipients, Reduced IntensityRecipients Myeloablative Regimen
Started643330
Completed643330
Not completed000

Outcome measures

PrimaryPercentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.

Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.

Time frame:
donation
Reported as:
Count of participants · Participants
Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.
ParticipantsRelated Donors Receiving Plerixafor
Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.63
Statistical analysis
  • Related Donors Receiving Plerixafor ·
SecondaryIncidence and Severity of Acute Toxicities

Incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor. Acute toxicities are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Grade of maximum toxicity across all time points is reported. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.

Time frame:
baseline, Day 1, Day 2, Day 3
Reported as:
Count of participants · Participants
Incidence and Severity of Acute Toxicities
ParticipantsRelated Donors Receiving Plerixafor
Max Modified toxicity criteria (MTC) = 019
Max Modified toxicity criteria (MTC) = 134
Max Modified toxicity criteria (MTC) = 210
Max Modified toxicity criteria (MTC) = 31
Statistical analysis
  • Related Donors Receiving Plerixafor ·
SecondaryAdverse Effects

Adverse effects experienced by donors receiving plerixafor up to one year post donation. Number of participants with a maximum MTC \>0 reported at each individual time point. Adverse effects are graded according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. This outcome measure is descriptive. Participants can experience adverse effects at more than one time point evaluated. Higher grades denote worse outcomes. 0 = None, 1 = Mild, 2 = Moderate, 3 = severe.

Time frame:
30 minutes, 60 minutes, 120 minutes, 240 minutes, 1 month, 6 months, 12 months post donation for each subject
Reported as:
Count of participants · Participants
Adverse Effects
ParticipantsRelated Donors Receiving Plerixafor
30 minutes after administration of plerixafor23
60 minutes after administration of plerixafor28
120 minutes after administration of plerixafor27
240 minutes after administration of plerixafor24
One month after administration of plerixafor22
Six months after administration of plerixafor7
Twelve months after administration of plerixafor7
Statistical analysis
  • Related Donors Receiving Plerixafor ·
SecondaryIncidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

Incidence of and kinetics of neutrophil and platelet recovery by day 100 in recipients after transplantation of hematopoietic cells mobilized with plerixafor.

Time frame:
Day +1 through neutrophil recovery or Day 21 (whichever is first)
Reported as:
Number · Percentage probability of engraftment
Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
Percentage probability of engraftmentRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Neutrophil engraftment100 (100 to 100)100 (100 to 100)
Platelet engraftment100 (100 to 100)97 (97 to 100)
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryT-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

T-cell (CD3+) and myeloid (CD33+) chimerism in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.

Time frame:
Chimerism was evaluated at serial timepoints post HCT in patients in both RIC and MAC strata. Chimerism was assessed at Day +28, +100, +180, and +365
Reported as:
Median · percentage of donor cell chimerism
T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
percentage of donor cell chimerismRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Myeloid chimerism (Day 28)100 (98 to 100)100 (91 to 100)
T-cell chimerism (Day 28)92 (59 to 100)80 (50 to 100)
Myeloid chimerism (Day 100)99 (91 to 100)100 (17 to 100)
T-cell chimerism (Day 100)97 (76 to 100)84 (64 to 100)
Myeloid chimerism (Day 180)100 (89 to 100)100 (5 to 100)
T-cell chimerism (Day 180)100 (91 to 100)95 (5 to 100)
Myeloid chimerism (Day 365)100 (100 to 100)100 (0 to 100)
T-cell chimerism (Day 365)100 (100 to 100)100 (0 to 100)
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryPrimary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

Incidence of primary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.

Time frame:
Day 28
Reported as:
Count of participants · Participants
Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
ParticipantsRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor00
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryIncidence of Acute Graft-versus-host Disease (GVHD)

Incidence of acute graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor

Time frame:
Day 100
Reported as:
Number · Percentage of participants
Incidence of Acute Graft-versus-host Disease (GVHD)
Percentage of participantsRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Grade 2-4 aGVHD by day 10053 (35 to 71)18 (7 to 33)
Grade 3-4 aGVHD by day 10017 (6 to 32)3 (0 to 12)
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryImmune Reconstitution

Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor.

Time frame:
Day 28, 100, 180, 365
Reported as:
Median · Cells*10^3/mm^3
Immune Reconstitution
Cells*10^3/mm^3Recipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
CD3+ (Day 28)589 (48 to 2250)478 (49 to 1485)
CD4+ (Day 28)363 (23 to 1364)214 (28 to 676)
CD8+ (Day 28)197 (19 to 837)127 (8 to 918)
CD3+ (Day100)647 (61 to 1671)529 (40 to 1387)
CD4+ (Day 100)339 (20 to 714)265 (25 to 650)
CD8+ (Day 100)242 (12 to 1069)162 (13 to 998)
CD3+ (Day 180)638 (58 to 1964)699 (69 to 1517)
CD4+ (Day 180)352 (16 to 851)257 (18 to 769)
CD8+ (Day 180)272 (26 to 1080)219 (37 to 862)
CD3+ (Day 365)794 (62 to 1780)1094 (207 to 2448)
CD4+ (Day 365)495 (27 to 932)457 (92 to 775)
CD8+ (Day 365)264 (25 to 963)460 (106 to 1608)
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryIncidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.

Percentage of recipients with prior CMV infection whose CMV was reactivated after transplantation with cell mobilized with plerixafor

Time frame:
day 365
Reported as:
Count of participants · Participants
Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.
ParticipantsRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.36
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryTreatment-related Mortality and Disease Relapse/Progression

Incidence of treatment-related mortality and disease relapse/progression in recipients after transplantation of hematopoietic cells mobilized with plerixafor

Time frame:
Day 180, 365
Reported as:
Number · Percentage probability of outcome
Treatment-related Mortality and Disease Relapse/Progression
Percentage probability of outcomeRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Treatment-related mortality (180 days)7 (1 to 18)3 (0 to 12)
Treatment-related mortality (365 days)17 (6 to 32)6 (1 to 17)
Relapse/progression of disease (180 days)30 (15 to 47)28 (14 to 45)
Relapse/progression of disease (365 days)30 (15 to 48)30 (16 to 47)
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryProgression-free and Overall Survival

Probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor

Time frame:
Day 180, 365
Reported as:
Number · Percentage probability of outcome
Progression-free and Overall Survival
Percentage probability of outcomeRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Progression free survival (180 days)63 (46 to 79)69 (52 to 83)
Progression free survival (365 days)53 (36 to 71)64 (47 to 79)
Overall survival (180 days)87 (72 to 96)79 (63 to 91)
Overall survival (365 days)63 (46 to 79)70 (53 to 84)
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryCellular Composition of Allografts

Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells)

Time frame:
donation
Reported as:
Median · cells*10^8/kg
Cellular Composition of Allografts
cells*10^8/kgRelated Donors Receiving Plerixafor
CD3+5.96 (2.72 to 13.0)
CD3+CD4+3.57 (2.0 to 9.4)
CD3+CD8+2.18 (0.48 to 5.0)
CD19+1.47 (0.23 to 7.43)
CD56+0.38 (0.0 to 1.10)
Statistical analysis
  • Related Donors Receiving Plerixafor ·
SecondaryIncidence of Chronic Graft-versus-host Disease (GVHD)

Incidence of chronic graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor

Time frame:
Day 365
Reported as:
Number · Percentage of participants
Incidence of Chronic Graft-versus-host Disease (GVHD)
Percentage of participantsRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Incidence of Chronic Graft-versus-host Disease (GVHD)52 (33 to 70)39 (23 to 57)
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondarySecondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor

Incidence of secondary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive.

Time frame:
Day 365
Reported as:
Count of participants · Participants
Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor
ParticipantsRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning Regimen
Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor00
Statistical analysis
  • Recipients, Myeloablative Conditioning Regimen vs Recipients, Reduced Intensity Conditioning Regimen ·
SecondaryCD34+ Cell Count of Allografts

CD34+ cell count of allografts mobilized with plerixafor

Time frame:
donation
Reported as:
Median · cells*10^6/kg
CD34+ Cell Count of Allografts
cells*10^6/kgRelated Donors Receiving Plerixafor
CD34+ Cell Count of Allografts4.68 (0.9 to 9.6)
Statistical analysis
  • Related Donors Receiving Plerixafor ·

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Related Donors Receiving Plerixafor—1/64 (1.6%)44/64 (68.8%)
Most frequent serious events
Most frequent serious events
EventRelated Donors Receiving Plerixafor
Vasovagal reactionVascular disorders1/64
Most frequent other events
Showing 10 of 13
Most frequent other events
EventRelated Donors Receiving Plerixafor
FlatulenceGeneral disorders19/64
ParesthesiaGeneral disorders17/64
BloatingGeneral disorders15/64
DiarrheaGeneral disorders15/64
Abdominal painGeneral disorders13/64
Injection site reactionSurgical and medical procedures12/64
DizzinessGeneral disorders11/64
NauseaGeneral disorders10/64
HeadacheGeneral disorders9/64
UrticariaGeneral disorders3/64

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Related Donors Receiving PlerixaforRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning RegimenTotal
<=18 years1001
Between 18 and 65 years613030121
>=65 years2035
Sex: Female, Male
Sex: Female, Male(Participants)Related Donors Receiving PlerixaforRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning RegimenTotal
Female23142461
Male4116966
Region of Enrollment
Region of Enrollment(participants)Related Donors Receiving PlerixaforRecipients, Myeloablative Conditioning RegimenRecipients, Reduced Intensity Conditioning RegimenTotal
United States643033127
08

Study locations

12 sites
  • H. Lee Moffitt Cancer Center
    Tampa, Florida, United States
  • Emory University
    Atlanta, Georgia, United States
  • University of Chicago
    Chicago, Illinois, United States
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
  • University of Minnesota
    Minneapolis, Minnesota, United States
  • Mayo Clinic
    Rochester, Minnesota, United States
  • Washington University
    St Louis, Missouri, United States
  • Duke University
    Durham, North Carolina, United States
  • Cleveland Clinic
    Cleveland, Ohio, United States
  • Ohio State University
    Columbus, Ohio, United States
  • West Virginia University
    Morgantown, West Virginia, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin, United States
09

References and documents

Publications

  • Chen YB, Le-Rademacher J, Brazauskas R, Kiefer DM, Hamadani M, DiPersio JF, Litzow MR, Craig M, Horwitz ME, Artz AS, McClune BL, Fernandez HF, Duong HK, Kobusingye H, Proue M, Drexler RJ, Horowitz MM, Shaw BE, Miller JP, Hosoba S, Waller EK, Devine SM. Plerixafor alone for the mobilization and transplantation of HLA-matched sibling donor hematopoietic stem cells. Blood Adv. 2019 Mar 26;3(6):875-883. doi: 10.1182/bloodadvances.2018027599. PubMed 30890544 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01696461
Lead sponsor
Center for International Blood and Marrow Transplant Research
Collaborators
Genzyme, a Sanofi Company, Sanofi
Responsible party
Sponsor
First posted
Oct 1, 2012
Start date
May 2013
Primary completion
Aug 2016
Completion
Aug 2016
Results posted
Sep 14, 2023
Last update
Sep 14, 2023

Study contacts

Steve Devine, MD
principal investigator · NMDP/BeTheMatch

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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