A Phase II Study Evaluating the Safety and Efficacy of Su... | NCT01696461

NCT01696461

Status Module

Name	Class
Genzyme, a Sanofi Company	INDUSTRY
Sanofi	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Related donors receiving plerixafor	Experimental	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
Recipients, myeloablative regimen	No Intervention	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
Recipients, reduced intensity conditioning regimen.	No Intervention	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)

Name	Type	Description	Arm Group Labels	Other Names
Plerixafor	Drug		Related donors receiving plerixafor	Mozobil AMD3000

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	donation

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Steve Devine, MD	NMDP/BeTheMatch	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
H. Lee Moffitt Cancer Center		Tampa	Florida		United States
Emory University

PubMed Identifier	Type	Citation	Retractions
30890544	Derived	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Related Donors Receiving Plerixafor	Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent. Donor eligibility was determined according to institutional standards Donors met the following criteria: 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 106/kg.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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
BG002	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)
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00064 BG00130 BG00233 BG003127

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Recipients were not mobilized with plerixafor.

Posted

Count of Participants

Participants

donation

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG00064

Title

Denominators

Categories

Title	Measurements
	OG00063

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000																		Other		Percentage of donors mobilized with plerixafor. No comparison group was analyzed.

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.

Recipients were not analyzed for this outcome measure

Posted

Count of Participants

Participants

baseline, Day 1, Day 2, Day 3

ID	Title	Description
OG000	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 106/kg. Plerixafor

Units	Counts
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.

Recipients did not receive plerixafor and were not examined for this outcome.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Related Donors Receiving Plerixafor	Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent. Donor eligibility was determined according to institutional standards Donors met the following criteria: 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 106/kg.

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.

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.

Posted

Number

95% Confidence Interval

Percentage probability of engraftment

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

ID	Title	Description
OG000	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
OG001	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)

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.

Chimerism is not evaluated in donor arm.

Posted

Median

Full Range

percentage of donor cell chimerism

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

ID	Title	Description
OG000	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
OG001	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)

Units	Counts

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.

Donor population did not receive a transplant

Posted

Count of Participants

Participants

Day 28

ID	Title	Description
OG000	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
OG001	Recipients, Reduced Intensity Conditioning Regimen	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)

Units	Counts
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

Donor arm did not receive a transplant. This group was not analyzed for graft-vs-host disease

Posted

Number

95% Confidence Interval

Percentage of participants

Day 100

ID	Title	Description
OG000	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
OG001	Recipients, Reduced Intensity Conditioning Regimen	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)

Units	Counts
Participants

Secondary

Immune Reconstitution

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

Donor population did not receive a transplant. Immune reconstitution was not measured in the donor population.

Posted

Median

Full Range

Cells*10^3/mm^3

Day 28, 100, 180, 365

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

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

Donor population did not receive a transplant. Only those with prior infection were eligible to be analyzed for this outcome measure

Posted

Count of Participants

Participants

day 365

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

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

Related donors did not receive a transplant and were not examined for this outcome.

Posted

Number

95% Confidence Interval

Percentage probability of outcome

Day 180, 365

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

Secondary

Progression-free and Overall Survival

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

Donor population did not receive a transplantation and therefore was not analyzed for this outcome

Posted

Number

95% Confidence Interval

Percentage probability of outcome

Day 180, 365

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

Secondary

Cellular Composition of Allografts

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

Posted

Median

Full Range

cells*10^8/kg

donation

ID	Title	Description
OG000	Related Donors Receiving Plerixafor	Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent. Donor eligibility was determined according to institutional standards Donors met the following criteria: 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 106/kg.

Units	Counts
Participants	OG000

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

Donor arm did not receive a transplant. This group was not analyzed for graft-versus-host disease.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 365

ID	Title	Description
OG000	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
OG001	Recipients, Reduced Intensity Conditioning Regimen	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)

Units	Counts
Participants

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.

Donor population did not receive a transplant.

Posted

Count of Participants

Participants

Day 365

ID	Title	Description
OG000	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
OG001	Recipients, Reduced Intensity Conditioning Regimen	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)

Units	Counts
Participants

Secondary

CD34+ Cell Count of Allografts

CD34+ cell count of allografts mobilized with plerixafor

Posted

Median

Full Range

cells*10^6/kg

donation

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Related Donors Receiving Plerixafor	Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent. Donor eligibility was determined according to institutional standards Donors met the following criteria: 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 106/kg.			1	64	44	64

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Periorbital edema	General disorders	Systematic Assessment	EG0001 affected64 at risk
Urticaria	General disorders	Systematic Assessment	EG0003 affected64 at risk
Headache	General disorders	Systematic Assessment	EG0009 affected64 at risk
Paresthesia	General disorders	Systematic Assessment	EG00017 affected64 at risk
Dizziness	General disorders	Systematic Assessment	EG00011 affected64 at risk
Nausea	General disorders	Systematic Assessment	EG00010 affected64 at risk
Vomiting	General disorders	Systematic Assessment	EG0003 affected64 at risk
Bloating	General disorders	Systematic Assessment	EG00015 affected64 at risk
Diarrhea	General disorders	Systematic Assessment	EG00015 affected64 at risk
Flatulence	General disorders	Systematic Assessment	EG00019 affected64 at risk
Abdominal pain	General disorders	Systematic Assessment	EG00013 affected64 at risk
Arthalgia	General disorders	Systematic Assessment	EG0001 affected64 at risk
Injection site reaction	Surgical and medical procedures	Systematic Assessment	EG00012 affected64 at risk

ID	Term
D015470	Leukemia, Myeloid, Acute
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D009190	Myelodysplastic Syndromes
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D001855	Bone Marrow Diseases
D009196	Myeloproliferative Disorders
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008223	Lymphoma
D015448	Leukemia, B-Cell