Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Hodgkin's Disease, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Related Donors Donating Peripheral Blood Stem Cells (PBSC) to a Family Member
Conditions
Brief 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.
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.
Interventions
DRUGPlerixafor
Sponsors
Genzyme, a Sanofi Company
Sanofi
Center for International Blood and Marrow Transplant Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | donation | Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects | 30 minutes, 60 minutes, 120 minutes, 240 minutes, 1 month, 6 months, 12 months post donation for each subject | 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. |
| Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Day +1 through neutrophil recovery or Day 21 (whichever is first) | Incidence of and kinetics of neutrophil and platelet recovery by day 100 in recipients after transplantation of hematopoietic cells mobilized with plerixafor. |
| T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | 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 | T-cell (CD3+) and myeloid (CD33+) chimerism in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive. |
| Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Day 28 | Incidence of primary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive. |
| Incidence of Acute Graft-versus-host Disease (GVHD) | Day 100 | Incidence of acute graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor |
| Immune Reconstitution | Day 28, 100, 180, 365 | Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor. |
| Incidence and Severity of Acute Toxicities | baseline, Day 1, Day 2, Day 3 | 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. |
| Treatment-related Mortality and Disease Relapse/Progression | Day 180, 365 | Incidence of treatment-related mortality and disease relapse/progression in recipients after transplantation of hematopoietic cells mobilized with plerixafor |
| Progression-free and Overall Survival | Day 180, 365 | Probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor |
| Cellular Composition of Allografts | donation | Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells) |
| Incidence of Chronic Graft-versus-host Disease (GVHD) | Day 365 | Incidence of chronic graft-versus-host disease (GVHD) in recipients after transplantation of hematopoietic cells mobilized with plerixafor |
| Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Day 365 | Incidence of secondary graft failure in recipients after transplantation of hematopoietic cells mobilized with plerixafor. This outcome measure is descriptive. |
| CD34+ Cell Count of Allografts | donation | CD34+ cell count of allografts mobilized with plerixafor |
| Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor. | day 365 | Percentage of recipients with prior CMV infection whose CMV was reactivated after transplantation with cell mobilized with plerixafor |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 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 10E6/kg. | 64 |
| Recipients, Myeloablative Conditioning 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 | 30 |
| Recipients, 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) | 33 |
| Total | 127 |
Baseline characteristics
| Characteristic | Related Donors Receiving Plerixafor | Recipients, Myeloablative Conditioning Regimen | Recipients, Reduced Intensity Conditioning Regimen | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 30 Participants | 30 Participants | 121 Participants |
| Region of Enrollment United States | 64 participants | 30 participants | 33 participants | 127 participants |
| Sex: Female, Male Female | 23 Participants | 14 Participants | 24 Participants | 61 Participants |
| Sex: Female, Male Male | 41 Participants | 16 Participants | 9 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 64 |
| serious Total, serious adverse events | 1 / 64 |
Outcome results
Primary
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
Population: Recipients were not mobilized with plerixafor.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Related 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 Participants |
Secondary
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
Population: Recipients did not receive plerixafor and were not examined for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Adverse Effects | 30 minutes after administration of plerixafor | 23 Participants |
| Related Donors Receiving Plerixafor | Adverse Effects | 60 minutes after administration of plerixafor | 28 Participants |
| Related Donors Receiving Plerixafor | Adverse Effects | 120 minutes after administration of plerixafor | 27 Participants |
| Related Donors Receiving Plerixafor | Adverse Effects | 240 minutes after administration of plerixafor | 24 Participants |
| Related Donors Receiving Plerixafor | Adverse Effects | One month after administration of plerixafor | 22 Participants |
| Related Donors Receiving Plerixafor | Adverse Effects | Six months after administration of plerixafor | 7 Participants |
| Related Donors Receiving Plerixafor | Adverse Effects | Twelve months after administration of plerixafor | 7 Participants |
Secondary
CD34+ Cell Count of Allografts
CD34+ cell count of allografts mobilized with plerixafor
Time frame: donation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Related Donors Receiving Plerixafor | CD34+ Cell Count of Allografts | 4.68 cells*10^6/kg |
Secondary
Cellular Composition of Allografts
Cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/ (Natural killer) NK-cells)
Time frame: donation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Cellular Composition of Allografts | CD3+ | 5.96 cells*10^8/kg |
| Related Donors Receiving Plerixafor | Cellular Composition of Allografts | CD3+CD4+ | 3.57 cells*10^8/kg |
| Related Donors Receiving Plerixafor | Cellular Composition of Allografts | CD3+CD8+ | 2.18 cells*10^8/kg |
| Related Donors Receiving Plerixafor | Cellular Composition of Allografts | CD19+ | 1.47 cells*10^8/kg |
| Related Donors Receiving Plerixafor | Cellular Composition of Allografts | CD56+ | 0.38 cells*10^8/kg |
Comparison: This outcome measure is descriptive.
Secondary
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
Population: Donor population did not receive a transplant. Immune reconstitution was not measured in the donor population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD3+ (Day 28) | 589 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD4+ (Day 28) | 363 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD8+ (Day 28) | 197 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD3+ (Day100) | 647 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD4+ (Day 100) | 339 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD8+ (Day 100) | 242 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD3+ (Day 180) | 638 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD4+ (Day 180) | 352 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD8+ (Day 180) | 272 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD3+ (Day 365) | 794 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD4+ (Day 365) | 495 Cells*10^3/mm^3 |
| Related Donors Receiving Plerixafor | Immune Reconstitution | CD8+ (Day 365) | 264 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD4+ (Day 365) | 457 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD3+ (Day 28) | 478 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD3+ (Day 180) | 699 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD4+ (Day 28) | 214 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD3+ (Day 365) | 1094 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD8+ (Day 28) | 127 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD4+ (Day 180) | 257 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD3+ (Day100) | 529 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD8+ (Day 365) | 460 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD4+ (Day 100) | 265 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD8+ (Day 180) | 219 Cells*10^3/mm^3 |
| Recipients, Reduced Intensity Conditioning Regimen | Immune Reconstitution | CD8+ (Day 100) | 162 Cells*10^3/mm^3 |
Secondary
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
Population: Recipients were not analyzed for this outcome measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Incidence and Severity of Acute Toxicities | Max Modified toxicity criteria (MTC) = 0 | 19 Participants |
| Related Donors Receiving Plerixafor | Incidence and Severity of Acute Toxicities | Max Modified toxicity criteria (MTC) = 1 | 34 Participants |
| Related Donors Receiving Plerixafor | Incidence and Severity of Acute Toxicities | Max Modified toxicity criteria (MTC) = 2 | 10 Participants |
| Related Donors Receiving Plerixafor | Incidence and Severity of Acute Toxicities | Max Modified toxicity criteria (MTC) = 3 | 1 Participants |
Secondary
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
Population: Donor arm did not receive a transplant. This group was not analyzed for graft-vs-host disease
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Incidence of Acute Graft-versus-host Disease (GVHD) | Grade 2-4 aGVHD by day 100 | 53 Percentage of participants |
| Related Donors Receiving Plerixafor | Incidence of Acute Graft-versus-host Disease (GVHD) | Grade 3-4 aGVHD by day 100 | 17 Percentage of participants |
| Recipients, Reduced Intensity Conditioning Regimen | Incidence of Acute Graft-versus-host Disease (GVHD) | Grade 2-4 aGVHD by day 100 | 18 Percentage of participants |
| Recipients, Reduced Intensity Conditioning Regimen | Incidence of Acute Graft-versus-host Disease (GVHD) | Grade 3-4 aGVHD by day 100 | 3 Percentage of participants |
Comparison: The cumulative incidence of acute graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.
Secondary
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)
Population: Patients were classified to one of the two conditioning regimens - myeloablative (MAC) or reduced intensity conditioning (RIC). A total of 30 MAC and 33 RIC patients were analyzed for this outcome. Neutrophil engraftment was defined as time from day 0 of HCT to the first of 3 consecutive measurements of absolute neutrophil count ≥0.5 × 109/L. Platelet engraftment was defined as the number of days from day 0 of HCT to the first of 3 consecutive values of platelet count ≥20 × 109/L.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Neutrophil engraftment | 100 Percentage probability of engraftment |
| Related Donors Receiving Plerixafor | Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Platelet engraftment | 100 Percentage probability of engraftment |
| Recipients, Reduced Intensity Conditioning Regimen | Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Neutrophil engraftment | 100 Percentage probability of engraftment |
| Recipients, Reduced Intensity Conditioning Regimen | Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Platelet engraftment | 97 Percentage probability of engraftment |
Secondary
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
Population: Donor arm did not receive a transplant. This group was not analyzed for graft-versus-host disease.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Related Donors Receiving Plerixafor | Incidence of Chronic Graft-versus-host Disease (GVHD) | 52 Percentage of participants |
| Recipients, Reduced Intensity Conditioning Regimen | Incidence of Chronic Graft-versus-host Disease (GVHD) | 39 Percentage of participants |
Comparison: The cumulative incidence of chronic graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.
Secondary
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
Population: Donor population did not receive a transplant. Only those with prior infection were eligible to be analyzed for this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Related Donors Receiving Plerixafor | Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor. | 3 Participants |
| Recipients, Reduced Intensity Conditioning Regimen | Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor. | 6 Participants |
Comparison: Groups were not directly compared using a statistical test.
Secondary
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
Population: Donor population did not receive a transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Related Donors Receiving Plerixafor | Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | 0 Participants |
| Recipients, Reduced Intensity Conditioning Regimen | Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | 0 Participants |
Secondary
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
Population: Donor population did not receive a transplantation and therefore was not analyzed for this outcome
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Progression-free and Overall Survival | Progression free survival (180 days) | 63 Percentage probability of outcome |
| Related Donors Receiving Plerixafor | Progression-free and Overall Survival | Progression free survival (365 days) | 53 Percentage probability of outcome |
| Related Donors Receiving Plerixafor | Progression-free and Overall Survival | Overall survival (180 days) | 87 Percentage probability of outcome |
| Related Donors Receiving Plerixafor | Progression-free and Overall Survival | Overall survival (365 days) | 63 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Progression-free and Overall Survival | Overall survival (365 days) | 70 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Progression-free and Overall Survival | Progression free survival (180 days) | 69 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Progression-free and Overall Survival | Overall survival (180 days) | 79 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Progression-free and Overall Survival | Progression free survival (365 days) | 64 Percentage probability of outcome |
Comparison: The probability of progression free survival and overall survival were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.
Secondary
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
Population: Donor population did not receive a transplant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Related Donors Receiving Plerixafor | Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | 0 Participants |
| Recipients, Reduced Intensity Conditioning Regimen | Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | 0 Participants |
Secondary
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
Population: Chimerism is not evaluated in donor arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 28) | 100 percentage of donor cell chimerism |
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 28) | 92 percentage of donor cell chimerism |
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 100) | 99 percentage of donor cell chimerism |
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 100) | 97 percentage of donor cell chimerism |
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 180) | 100 percentage of donor cell chimerism |
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 180) | 100 percentage of donor cell chimerism |
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 365) | 100 percentage of donor cell chimerism |
| Related Donors Receiving Plerixafor | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 365) | 100 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 365) | 100 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 28) | 100 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 180) | 100 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 28) | 80 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 365) | 100 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | Myeloid chimerism (Day 100) | 100 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 180) | 95 percentage of donor cell chimerism |
| Recipients, Reduced Intensity Conditioning Regimen | T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor | T-cell chimerism (Day 100) | 84 percentage of donor cell chimerism |
Secondary
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
Population: Related donors did not receive a transplant and were not examined for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Related Donors Receiving Plerixafor | Treatment-related Mortality and Disease Relapse/Progression | Treatment-related mortality (180 days) | 7 Percentage probability of outcome |
| Related Donors Receiving Plerixafor | Treatment-related Mortality and Disease Relapse/Progression | Treatment-related mortality (365 days) | 17 Percentage probability of outcome |
| Related Donors Receiving Plerixafor | Treatment-related Mortality and Disease Relapse/Progression | Relapse/progression of disease (180 days) | 30 Percentage probability of outcome |
| Related Donors Receiving Plerixafor | Treatment-related Mortality and Disease Relapse/Progression | Relapse/progression of disease (365 days) | 30 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Treatment-related Mortality and Disease Relapse/Progression | Relapse/progression of disease (365 days) | 30 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Treatment-related Mortality and Disease Relapse/Progression | Treatment-related mortality (180 days) | 3 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Treatment-related Mortality and Disease Relapse/Progression | Relapse/progression of disease (180 days) | 28 Percentage probability of outcome |
| Recipients, Reduced Intensity Conditioning Regimen | Treatment-related Mortality and Disease Relapse/Progression | Treatment-related mortality (365 days) | 6 Percentage probability of outcome |
Comparison: The probability of treatment-related mortality and disease relapse/progression were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.