Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

• Sponsor: Genzyme, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00103610
• Collaborator: (none)
• Enrollment: 298
• Locations: 32
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin	Drug: Granulocyte colony-stimulating factor plus plerixafor; Drug: Granulocyte colony-stimulating factor plus placebo	Phase 3

Detailed Description

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim is better than filgrastim alone in helping non-Hodgkin's lymphoma patients collect at least 5 million stem cells in four or less apheresis sessions.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 298 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 5 * 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: G-CSF plus plerixafor	Drug: Granulocyte colony-stimulating factor plus plerixafor; Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.; Other Names: AMD3100 Mozobil
Placebo Comparator: G-CSF plus placebo	Drug: Granulocyte colony-stimulating factor plus placebo; Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis [Days 5 to 8]

   Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Secondary Outcome Measures

1. Number of Participants With Adverse Events [up to Day 38]

   Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.

2. Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis [up to Day 8]

   Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

3. Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg [up to Day 8]

   The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.

4. Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment [Up to Month 13]

   The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.

5. Median Number of Days to Platelet (PLT) Engraftment [Up to Month 13]

   The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.

6. Graft Durability at 100 Days Post Transplantation [approximately Day 138]

   The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.

7. Graft Durability at 6 Months Post Transplantation [approximately Month 7]

   The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.

8. Graft Durability at 12 Months Post Transplantation [approximately Month 13]

   The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria (Abbreviated List):

• Non-Hodgkin's lymphoma in first or second complete or partial remission

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• White Blood Cell count (WBC) > 2.5*10^9/L

• Platelet (PLT) > 100*10^9/L

Exclusion Criteria (Abbreviated List):

• Failed previous stem cell collection

• Prior autologous or allogeneic transplant

• Brain metastases or bone marrow involvement > 20%

• Radiation to pelvis

• Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Samaritan Bone Marrow Transplant Program	Phoenix	Arizona	United States	85006
2	City of Hope National Medical Center	Duarte	California	United States	91010
3	Rocky Mountain Cancer Center	Denver	Colorado	United States	80218
4	Yale University School of Medicine	New Haven	Connecticut	United States	06520
5	Shands Teaching Hospital, University of Florida	Gainesville	Florida	United States	32610
6	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
7	Loyola University Medical Center	Maywood	Illinois	United States	60153
8	Indiana Blood and Marrow Transplantation Center	Beech Grove	Indiana	United States	46107
9	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
10	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
11	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
12	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
13	University of Minnesota	Minneapolis	Minnesota	United States	55455
14	Mayo Clinic	Rochester	Minnesota	United States	55905
15	Kansas City Cancer Center	Kansas City	Missouri	United States	64111
16	Washington University School of Medicine	St. Louis	Missouri	United States	63110
17	Nebraska Medical Center: Clarkson and University Hospitals	Omaha	Nebraska	United States	68198
18	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
19	University of Rochester Medical Center	Rochester	New York	United States	14642
20	Duke University Medical Center	Durham	North Carolina	United States	27705
21	Case Western Reserve University	Cleveland	Ohio	United States	44106
22	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
23	Oregon Health & Science University	Portland	Oregon	United States	97239
24	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
25	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
26	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
27	Wilford Hall Medical Center	Lackland AFB	Texas	United States	78236
28	Texas Transplant Institute	San Antonio	Texas	United States	78229
29	University of Texas Health Science Center	San Antonio	Texas	United States	78229
30	Virginia Commonwealth University	Richmond	Virginia	United States	23298
31	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
32	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9

Sponsors and Collaborators

• Genzyme, a Sanofi Company

Investigators

• Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Further information on non-Hodgkin's lymphoma from the National Cancer Institute

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00103610
• Other Study ID Numbers: AMD3100-3101; NCT00248508
• First Posted: Feb 14, 2005
• Last Update Posted: Mar 13, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by , ,: Non-Hodgkin's lymphoma; Stem cell mobilization
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Plerixafor; Lenograstim

Study Results

Participant Flow

Recruitment Details	Participants with non-Hodgkin's lymphoma (NHL) eligible for autologous hematopoietic stem cell transplant were recruited from 31 centers in the U.S. and 1 in Canada. The first participant was randomized on 18 January 2005 and the last participant's last study visit occurred on 20 December 2007. A total of 298 participants were randomized.

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Period Title: Overall Study
STARTED	150	148
COMPLETED	112	68
NOT COMPLETED	38	80

Baseline Characteristics

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo	Total
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Total of all reporting groups
Overall Participants	150	148	298
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.1 (10.9)	57.5 (10.3)	56.3 (10.7)
Sex: Female, Male (Count of Participants)
Female	50 33.3%	46 31.1%	96 32.2%
Male	100 66.7%	102 68.9%	202 67.8%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	136 90.7%	140 94.6%	276 92.6%
African-American	6 4%	1 0.7%	7 2.3%
Asian	2 1.3%	2 1.4%	4 1.3%
Hispanic/Latino	5 3.3%	4 2.7%	9 3%
Other	1 0.7%	1 0.7%	2 0.7%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
Description	Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
Time Frame	Days 5 to 8

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	150	148
Proportion achieving target in ≤4 days	0.593 0.4%	0.196 0.1%
Proportion not achieving target in ≤4 days	0.407 0.3%	0.804 0.5%

2. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.
Time Frame	up to Day 38

Outcome Measure Data

Analysis Population Description

Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	150	145
Adverse Events (AEs)	146 97.3%	138 93.2%
Related AEs	98 65.3%	60 40.5%
AEs Leading to early treatment termination	3 2%	3 2%
AEs Leading to early study termination	2 1.3%	4 2.7%
Grade 3 (severe) or 4 (life-threatening) AEs	11 7.3%	14 9.5%
SAEs	8 5.3%	10 6.8%

3. Secondary Outcome

Title	Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
Description	Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
Time Frame	up to Day 8

Outcome Measure Data

Analysis Population Description

Intent-to-treat Population

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	150	148
Proportion achieving target in ≤4 days	0.867 0.6%	0.473 0.3%
Proportion not achieving target in ≤4 days	0.133 0.1%	0.527 0.4%

4. Secondary Outcome

Title	Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg
Description	The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.
Time Frame	up to Day 8

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population.

Arm/Group Title	G-CSF + Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	147	142
Median (Inter-Quartile Range) [Days]	3.0	NA

5. Secondary Outcome

Title	Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Description	The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Time Frame	Up to Month 13

Outcome Measure Data

Analysis Population Description

Participants who received a stem cell transplant.

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	135	82
Median (Inter-Quartile Range) [Days]	10.0	10.0

6. Secondary Outcome

Title	Median Number of Days to Platelet (PLT) Engraftment
Description	The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.
Time Frame	Up to Month 13

Outcome Measure Data

Analysis Population Description

Participants who received a stem cell transplant

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	135	82
Median (Inter-Quartile Range) [Days]	20.0	20.0

7. Secondary Outcome

Title	Graft Durability at 100 Days Post Transplantation
Description	The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
Time Frame	approximately Day 138

Outcome Measure Data

Analysis Population Description

Participants who received a stem cell transplant and were evaluable at 100 days post-transplant

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	135	82
Proportion of participants with durable graft	0.948 0.6%	0.951 0.6%
Proportion of participants without durable graft	0.052 0%	0.049 0%

8. Secondary Outcome

Title	Graft Durability at 6 Months Post Transplantation
Description	The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
Time Frame	approximately Month 7

Outcome Measure Data

Analysis Population Description

Participants who received a stem cell transplant and were evaluable at 6 months post-transplant

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	123	78
Proportion of participants with a durable graft	0.976 0.7%	0.987 0.7%
Proportion of participants without a durable graft	0.024 0%	0.013 0%

9. Secondary Outcome

Title	Graft Durability at 12 Months Post Transplantation
Description	The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
Time Frame	approximately Month 13

Outcome Measure Data

Analysis Population Description

Participants who received a stem cell transplant and were evaluable at 12 months post-transplant

Arm/Group Title	G-CSF Plus Plerixafor	G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Measure Participants	112	65
Proportion of participants with a durable graft	0.982 0.7%	1.0 0.7%
Proportion of participants without a durable graft	0.018 0%	0.0 0%

Adverse Events

Time Frame	Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).
Adverse Event Reporting Description	Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Arm/Group Title	G-CSF Plus Plerixafor		G-CSF Plus Placebo
Arm/Group Description	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.		Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
All Cause Mortality
	G-CSF Plus Plerixafor		G-CSF Plus Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	G-CSF Plus Plerixafor		G-CSF Plus Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/150 (5.3%)		10/145 (6.9%)
Blood and lymphatic system disorders
Febrile neutropenia	1/150 (0.7%)		0/145 (0%)
Thrombocytopenia	1/150 (0.7%)		0/145 (0%)
Cardiac disorders
Atrial fibrillation	0/150 (0%)		2/145 (1.4%)
Gastrointestinal disorders
Abdominal pain lower	0/150 (0%)		1/145 (0.7%)
General disorders
Non-cardiac chest pain	0/150 (0%)		1/145 (0.7%)
Pyrexia	1/150 (0.7%)		0/145 (0%)
Infections and infestations
Bacteraemia	0/150 (0%)		1/145 (0.7%)
Bacterial sepsis	0/150 (0%)		1/145 (0.7%)
Catheter bacteraemia	1/150 (0.7%)		0/145 (0%)
Pseudomonal sepsis	0/150 (0%)		1/145 (0.7%)
Sinusitis	0/150 (0%)		1/145 (0.7%)
Musculoskeletal and connective tissue disorders
Back pain	1/150 (0.7%)		0/145 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system	0/150 (0%)		1/145 (0.7%)
Metastases to skin	1/150 (0.7%)		0/145 (0%)
Nervous system disorders
Convulsion	1/150 (0.7%)		0/145 (0%)
Dizziness	1/150 (0.7%)		0/145 (0%)
Renal and urinary disorders
Renal failure acute	0/150 (0%)		1/145 (0.7%)
Vascular disorders
Hypotension	1/150 (0.7%)		0/145 (0%)
Other (Not Including Serious) Adverse Events
	G-CSF Plus Plerixafor		G-CSF Plus Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	145/150 (96.7%)		136/145 (93.8%)
Blood and lymphatic system disorders
Anaemia	3/150 (2%)		5/145 (3.4%)
Lymphadenopathy	1/150 (0.7%)		2/145 (1.4%)
Thrombocytopenia	5/150 (3.3%)		5/145 (3.4%)
Cardiac disorders
Angina pectoris	0/150 (0%)		1/145 (0.7%)
Arrhythmia	0/150 (0%)		1/145 (0.7%)
Atrial fibrillation	1/150 (0.7%)		1/145 (0.7%)
Extrasystoles	2/150 (1.3%)		0/145 (0%)
Palpitations	2/150 (1.3%)		3/145 (2.1%)
Supraventricular tachycardia	1/150 (0.7%)		0/145 (0%)
Tachycardia	5/150 (3.3%)		4/145 (2.8%)
Ventricular extrasystoles	1/150 (0.7%)		0/145 (0%)
Ventricular tachyarrhythmia	0/150 (0%)		1/145 (0.7%)
Ear and labyrinth disorders
Tinnitus	1/150 (0.7%)		3/145 (2.1%)
Vertigo	3/150 (2%)		0/145 (0%)
Endocrine disorders
Hypothyroidism	1/150 (0.7%)		0/145 (0%)
Eye disorders
Eye swelling	1/150 (0.7%)		0/145 (0%)
Vision blurred	1/150 (0.7%)		1/145 (0.7%)
Gastrointestinal disorders
Abdominal discomfort	2/150 (1.3%)		1/145 (0.7%)
Abdominal distension	9/150 (6%)		3/145 (2.1%)
Abdominal pain	10/150 (6.7%)		4/145 (2.8%)
Abdominal pain upper	4/150 (2.7%)		0/145 (0%)
Constipation	2/150 (1.3%)		3/145 (2.1%)
Diarrhoea	65/150 (43.3%)		20/145 (13.8%)
Diarrhoea haemorrhagic	0/150 (0%)		1/145 (0.7%)
Dry mouth	5/150 (3.3%)		4/145 (2.8%)
Dyspepsia	4/150 (2.7%)		0/145 (0%)
Dysphagia	1/150 (0.7%)		0/145 (0%)
Eructation	1/150 (0.7%)		0/145 (0%)
Flatulence	11/150 (7.3%)		7/145 (4.8%)
Frequent bowel movements	5/150 (3.3%)		6/145 (4.1%)
Glossodynia	0/150 (0%)		1/145 (0.7%)
Haematochezia	1/150 (0.7%)		0/145 (0%)
Haemorrhoidal haemorrhage	0/150 (0%)		1/145 (0.7%)
Haemorrhoids	0/150 (0%)		1/145 (0.7%)
Hypoaesthesia oral	4/150 (2.7%)		0/145 (0%)
Inflammatory bowel disease	0/150 (0%)		1/145 (0.7%)
Nausea	50/150 (33.3%)		24/145 (16.6%)
Oral mucosal blistering	1/150 (0.7%)		0/145 (0%)
Oral mucosal petechiae	0/150 (0%)		1/145 (0.7%)
Paraesthesia oral	11/150 (7.3%)		13/145 (9%)
Periodontitis	1/150 (0.7%)		0/145 (0%)
Proctalgia	0/150 (0%)		1/145 (0.7%)
Rectal haemorrhage	1/150 (0.7%)		1/145 (0.7%)
Retching	2/150 (1.3%)		0/145 (0%)
Salivary hypersecretion	1/150 (0.7%)		0/145 (0%)
Stomach discomfort	4/150 (2.7%)		0/145 (0%)
Tooth disorder	1/150 (0.7%)		0/145 (0%)
Vomiting	12/150 (8%)		8/145 (5.5%)
General disorders
Asthenia	0/150 (0%)		2/145 (1.4%)
Catheter related complication	1/150 (0.7%)		0/145 (0%)
Catheter site discharge	2/150 (1.3%)		3/145 (2.1%)
Catheter site erythema	3/150 (2%)		8/145 (5.5%)
Catheter site haematoma	2/150 (1.3%)		1/145 (0.7%)
Catheter site haemorrhage	6/150 (4%)		7/145 (4.8%)
Catheter site oedema	0/150 (0%)		3/145 (2.1%)
Catheter site pain	18/150 (12%)		21/145 (14.5%)
Catheter site pruritus	2/150 (1.3%)		3/145 (2.1%)
Catheter site rash	2/150 (1.3%)		2/145 (1.4%)
Catheter site related reaction	2/150 (1.3%)		4/145 (2.8%)
Chest discomfort	1/150 (0.7%)		2/145 (1.4%)
Chest pain	0/150 (0%)		2/145 (1.4%)
Chills	3/150 (2%)		6/145 (4.1%)
Fatigue	40/150 (26.7%)		33/145 (22.8%)
Feeling abnormal	1/150 (0.7%)		0/145 (0%)
Feeling cold	2/150 (1.3%)		0/145 (0%)
Feeling hot	0/150 (0%)		2/145 (1.4%)
Immediate post-injection reaction	0/150 (0%)		1/145 (0.7%)
Influenza like illness	2/150 (1.3%)		2/145 (1.4%)
Injection site bruising	1/150 (0.7%)		3/145 (2.1%)
Injection site discomfort	1/150 (0.7%)		0/145 (0%)
Injection site erythema	48/150 (32%)		10/145 (6.9%)
Injection site haematoma	1/150 (0.7%)		0/145 (0%)
Injection site haemorrhage	1/150 (0.7%)		3/145 (2.1%)
Injection site irritation	7/150 (4.7%)		0/145 (0%)
Injection site pain	3/150 (2%)		4/145 (2.8%)
Injection site pruritus	12/150 (8%)		1/145 (0.7%)
Injection site rash	1/150 (0.7%)		1/145 (0.7%)
Injection site reaction	3/150 (2%)		2/145 (1.4%)
Injection site swelling	2/150 (1.3%)		0/145 (0%)
Injection site urticaria	4/150 (2.7%)		0/145 (0%)
Local swelling	1/150 (0.7%)		0/145 (0%)
Localised oedema	0/150 (0%)		1/145 (0.7%)
Malaise	1/150 (0.7%)		0/145 (0%)
Mucosal inflammation	1/150 (0.7%)		0/145 (0%)
Non-cardiac chest pain	2/150 (1.3%)		3/145 (2.1%)
Oedema	1/150 (0.7%)		0/145 (0%)
Oedema peripheral	16/150 (10.7%)		18/145 (12.4%)
Pain	12/150 (8%)		15/145 (10.3%)
Peripheral coldness	2/150 (1.3%)		0/145 (0%)
Pyrexia	9/150 (6%)		8/145 (5.5%)
Sensation of pressure	1/150 (0.7%)		0/145 (0%)
Submandibular mass	0/150 (0%)		1/145 (0.7%)
Infections and infestations
Bacteraemia	1/150 (0.7%)		0/145 (0%)
Body tinea	0/150 (0%)		1/145 (0.7%)
Bronchitis	0/150 (0%)		1/145 (0.7%)
Candidiasis	1/150 (0.7%)		0/145 (0%)
Catheter bacteraemia	0/150 (0%)		1/145 (0.7%)
Cellulitis	0/150 (0%)		1/145 (0.7%)
Central line infection	3/150 (2%)		1/145 (0.7%)
Erythema induratum	1/150 (0.7%)		1/145 (0.7%)
Folliculitis	1/150 (0.7%)		0/145 (0%)
Herpes zoster	1/150 (0.7%)		0/145 (0%)
Nasopharyngitis	0/150 (0%)		3/145 (2.1%)
Oral candidiasis	1/150 (0.7%)		1/145 (0.7%)
Oral herpes	0/150 (0%)		1/145 (0.7%)
Periodontal infection	0/150 (0%)		1/145 (0.7%)
Rectal abscess	0/150 (0%)		1/145 (0.7%)
Rhinitis	0/150 (0%)		1/145 (0.7%)
Sinusitis	2/150 (1.3%)		0/145 (0%)
Upper respiratory tract infection	3/150 (2%)		3/145 (2.1%)
Urinary tract infection	1/150 (0.7%)		0/145 (0%)
Viral upper respiratory tract infection	1/150 (0.7%)		0/145 (0%)
Injury, poisoning and procedural complications
Citrate toxicity	3/150 (2%)		2/145 (1.4%)
Contusion	5/150 (3.3%)		4/145 (2.8%)
Excoriation	1/150 (0.7%)		0/145 (0%)
Limb injury	0/150 (0%)		1/145 (0.7%)
Procedural pain	1/150 (0.7%)		2/145 (1.4%)
Road traffic accident	1/150 (0.7%)		0/145 (0%)
Skin laceration	1/150 (0.7%)		0/145 (0%)
Subcutaneous haematoma	1/150 (0.7%)		0/145 (0%)
Transfusion reaction	0/150 (0%)		1/145 (0.7%)
Investigations
Blood alkaline phosphatase increased	2/150 (1.3%)		3/145 (2.1%)
Blood creatinine increased	1/150 (0.7%)		0/145 (0%)
Blood magnesium decreased	1/150 (0.7%)		0/145 (0%)
Blood potassium decreased	1/150 (0.7%)		0/145 (0%)
Blood pressure decreased	0/150 (0%)		1/145 (0.7%)
Blood pressure increased	0/150 (0%)		1/145 (0.7%)
Blood uric acid increased	2/150 (1.3%)		8/145 (5.5%)
Body temperature increased	0/150 (0%)		2/145 (1.4%)
Breath sounds abnormal	2/150 (1.3%)		0/145 (0%)
Electrocardiogram T wave inversion	0/150 (0%)		1/145 (0.7%)
Hepatic enzyme increased	0/150 (0%)		1/145 (0.7%)
Platelet count decreased	1/150 (0.7%)		3/145 (2.1%)
Urine analysis abnormal	1/150 (0.7%)		0/145 (0%)
Weight increased	2/150 (1.3%)		1/145 (0.7%)
Metabolism and nutrition disorders
Anorexia	1/150 (0.7%)		3/145 (2.1%)
Decreased appetite	2/150 (1.3%)		1/145 (0.7%)
Dehydration	0/150 (0%)		1/145 (0.7%)
Fluid overload	1/150 (0.7%)		1/145 (0.7%)
Gout	2/150 (1.3%)		0/145 (0%)
Hyperglycaemia	1/150 (0.7%)		0/145 (0%)
Hyperuricaemia	3/150 (2%)		4/145 (2.8%)
Hypocalcaemia	4/150 (2.7%)		3/145 (2.1%)
Hypoglycaemia	1/150 (0.7%)		0/145 (0%)
Hypokalaemia	25/150 (16.7%)		20/145 (13.8%)
Hypomagnesaemia	17/150 (11.3%)		12/145 (8.3%)
Hypophosphataemia	2/150 (1.3%)		0/145 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	23/150 (15.3%)		19/145 (13.1%)
Back pain	31/150 (20.7%)		30/145 (20.7%)
Bone pain	40/150 (26.7%)		41/145 (28.3%)
Joint stiffness	0/150 (0%)		1/145 (0.7%)
Limb discomfort	1/150 (0.7%)		0/145 (0%)
Muscle spasms	7/150 (4.7%)		6/145 (4.1%)
Muscle twitching	0/150 (0%)		1/145 (0.7%)
Muscular weakness	2/150 (1.3%)		1/145 (0.7%)
Musculoskeletal chest pain	1/150 (0.7%)		5/145 (3.4%)
Musculoskeletal discomfort	2/150 (1.3%)		0/145 (0%)
Musculoskeletal pain	3/150 (2%)		4/145 (2.8%)
Musculoskeletal stiffness	2/150 (1.3%)		0/145 (0%)
Myalgia	3/150 (2%)		7/145 (4.8%)
Neck pain	3/150 (2%)		5/145 (3.4%)
Osteoarthritis	0/150 (0%)		1/145 (0.7%)
Pain in extremity	7/150 (4.7%)		10/145 (6.9%)
Pain in jaw	0/150 (0%)		1/145 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system	0/150 (0%)		1/145 (0.7%)
Non-Hodgkin's lymphoma	0/150 (0%)		1/145 (0.7%)
Nervous system disorders
Amnesia	0/150 (0%)		1/145 (0.7%)
Areflexia	1/150 (0.7%)		0/145 (0%)
Balance disorder	1/150 (0.7%)		0/145 (0%)
Convulsion	1/150 (0.7%)		0/145 (0%)
Dizziness	13/150 (8.7%)		8/145 (5.5%)
Dizziness postural	0/150 (0%)		1/145 (0.7%)
Dysgeusia	2/150 (1.3%)		1/145 (0.7%)
Headache	37/150 (24.7%)		27/145 (18.6%)
Hypoaesthesia	3/150 (2%)		6/145 (4.1%)
Hypogeusia	0/150 (0%)		1/145 (0.7%)
Neuropathy peripheral	1/150 (0.7%)		0/145 (0%)
Nystagmus	0/150 (0%)		1/145 (0.7%)
Paraesthesia	27/150 (18%)		30/145 (20.7%)
Peripheral sensory neuropathy	1/150 (0.7%)		0/145 (0%)
Poor quality sleep	0/150 (0%)		1/145 (0.7%)
Sedation	1/150 (0.7%)		0/145 (0%)
Sensory disturbance	0/150 (0%)		1/145 (0.7%)
Syncope	2/150 (1.3%)		0/145 (0%)
Syncope vasovagal	1/150 (0.7%)		0/145 (0%)
Tremor	2/150 (1.3%)		6/145 (4.1%)
Psychiatric disorders
Abnormal dreams	1/150 (0.7%)		0/145 (0%)
Anxiety	7/150 (4.7%)		7/145 (4.8%)
Confusional state	0/150 (0%)		1/145 (0.7%)
Depression	2/150 (1.3%)		0/145 (0%)
Hallucination	1/150 (0.7%)		0/145 (0%)
Insomnia	11/150 (7.3%)		4/145 (2.8%)
Nightmare	1/150 (0.7%)		0/145 (0%)
Restlessness	0/150 (0%)		1/145 (0.7%)
Sleep disorder	1/150 (0.7%)		0/145 (0%)
Renal and urinary disorders
Dysuria	3/150 (2%)		2/145 (1.4%)
Haematuria	0/150 (0%)		1/145 (0.7%)
Pollakiuria	1/150 (0.7%)		1/145 (0.7%)
Urine odour abnormal	1/150 (0.7%)		0/145 (0%)
Reproductive system and breast disorders
Breast swelling	1/150 (0.7%)		0/145 (0%)
Testicular pain	1/150 (0.7%)		0/145 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	7/150 (4.7%)		4/145 (2.8%)
Dyspnoea	6/150 (4%)		5/145 (3.4%)
Dyspnoea exertional	2/150 (1.3%)		1/145 (0.7%)
Haemoptysis	0/150 (0%)		1/145 (0.7%)
Nasal congestion	2/150 (1.3%)		2/145 (1.4%)
Nasal dryness	1/150 (0.7%)		0/145 (0%)
Obstructive airways disorder	1/150 (0.7%)		0/145 (0%)
Paranasal sinus hypersecretion	2/150 (1.3%)		0/145 (0%)
Pharyngolaryngeal pain	2/150 (1.3%)		2/145 (1.4%)
Pleural effusion	0/150 (0%)		1/145 (0.7%)
Rales	0/150 (0%)		1/145 (0.7%)
Rhinorrhoea	5/150 (3.3%)		2/145 (1.4%)
Sinus congestion	0/150 (0%)		1/145 (0.7%)
Sneezing	0/150 (0%)		1/145 (0.7%)
Throat irritation	1/150 (0.7%)		0/145 (0%)
Upper respiratory tract congestion	0/150 (0%)		2/145 (1.4%)
Wheezing	1/150 (0.7%)		0/145 (0%)
Skin and subcutaneous tissue disorders
Blister	1/150 (0.7%)		0/145 (0%)
Dermatitis	0/150 (0%)		1/145 (0.7%)
Dermatitis contact	1/150 (0.7%)		0/145 (0%)
Ecchymosis	1/150 (0.7%)		0/145 (0%)
Erythema	5/150 (3.3%)		2/145 (1.4%)
Hyperhidrosis	8/150 (5.3%)		3/145 (2.1%)
Hypoaesthesia facial	1/150 (0.7%)		1/145 (0.7%)
Night sweats	10/150 (6.7%)		4/145 (2.8%)
Pruritus	1/150 (0.7%)		3/145 (2.1%)
Pruritus generalised	0/150 (0%)		1/145 (0.7%)
Rash	6/150 (4%)		8/145 (5.5%)
Rash generalised	0/150 (0%)		1/145 (0.7%)
Rash pruritic	0/150 (0%)		1/145 (0.7%)
Skin irritation	1/150 (0.7%)		0/145 (0%)
Skin lesion	0/150 (0%)		1/145 (0.7%)
Urticaria	1/150 (0.7%)		0/145 (0%)
Urticaria localised	1/150 (0.7%)		0/145 (0%)
Vascular disorders
Flushing	8/150 (5.3%)		5/145 (3.4%)
Haematoma	1/150 (0.7%)		0/145 (0%)
Hot flush	3/150 (2%)		2/145 (1.4%)
Hypertension	1/150 (0.7%)		3/145 (2.1%)
Hypotension	8/150 (5.3%)		2/145 (1.4%)
Pallor	1/150 (0.7%)		1/145 (0.7%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.