Trial Outcomes & Findings for Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT) (NCT NCT01518153)

Last Updated: 2016-03-17

Results Overview

Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

100 days

Results posted on

2016-03-17

Participant Flow

Recruitment Period: February 6, 2012 to February 27, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned Donor Lymphocyte Infusion (DLI). 9 participants did not meet the criteria to receive randomized planned DLI.

Participant milestones

Participant milestones
Measure	Stem Cell Infusion Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.	Low Dose Donor T-Cells Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.	High Dose Donor T-Cells Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.
Donor Lymphocyte Infusion COMPLETED	0	1	3
Stem Cell Transplant STARTED	16	0	0
Stem Cell Transplant COMPLETED	7	0	0
Stem Cell Transplant NOT COMPLETED	9	0	0
Donor Lymphocyte Infusion STARTED	0	3	4
Donor Lymphocyte Infusion NOT COMPLETED	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Stem Cell Infusion Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.	Low Dose Donor T-Cells Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.	High Dose Donor T-Cells Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.
Stem Cell Transplant Active graft-vs-host disease (GvHD)	5	0	0
Stem Cell Transplant Death	2	0	0
Stem Cell Transplant Secondary graft failure	1	0	0
Stem Cell Transplant Adverse Event	1	0	0
Donor Lymphocyte Infusion Death	0	2	1

Baseline Characteristics

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stem Cell Transplant + Donor Lymphocyte Infusion n=16 Participants Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10\^6 CD3+ cells/kg or 3 x 10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\*10/L for 3 consecutive days.
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days

Population: Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI. 9 participants did not meet the criteria to receive randomized planned DLI.

Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).

Outcome measures

Outcome measures
Measure	Low Dose Donor T-Cells n=3 Participants Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.	High Dose Donor T-Cells n=4 Participants Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.
Success Rate	1 participants	3 participants

SECONDARY outcome

Timeframe: Every 3 months until day of death

Population: Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.

Overall Survival is defined as the interval between day of transplant and day of death.

Outcome measures

Outcome measures
Measure	Low Dose Donor T-Cells n=16 Participants Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.	High Dose Donor T-Cells Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.
Overall Survival (OS)	246 days Interval 26.0 to 504.0	—

Adverse Events

Stem Cell Infusion

Serious events: 9 serious events

Other events: 9 other events

Deaths: 0 deaths

Low Dose Donor T-Cells

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

High Dose Donor T-Cells

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Richard E. Champlin, MD/Chair, Stem Cell Transplantation

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-8750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Stem Cell Infusion n=9 participants at risk Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.	Low Dose Donor T-Cells n=3 participants at risk Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.	High Dose Donor T-Cells n=4 participants at risk Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.
General disorders Death	55.6% 5/9 • Number of events 5 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Blood and lymphatic system disorders Idiopathic Thrombocytopenic Purpura	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Pneumonia	33.3% 3/9 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Immune system disorders Secondary Graft Failure	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Enterococcus Faecium Stool Infection	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Parvovirus	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Disseminated Cytomegalovirus Infections	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Pseudomonas Bacteremia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Viral Exanthem	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Blood and lymphatic system disorders Deep Vein Thrombosis	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Hepatobiliary disorders Liver GvHD	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	75.0% 3/4 • Number of events 4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Pneumocystis Jiroveci (PCP) Pneumonia	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Fusarium Pneumonia	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Pulmonary Nocardiosis	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Pseudomonas Pneumonia	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
General disorders Neutropenic Fevers	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Staphylococcus Epidermidis Bacteremia	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Candida Albicans	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Renal and urinary disorders Escherichia Coli Urinary Tract Infection	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Renal and urinary disorders Staphylococcus Urinary Tract Infection	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Renal and urinary disorders Acute Tubular Necrosis	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Pseudomonas Tracheitis	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Blood and lymphatic system disorders Anoxic Brain Injury	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Vascular disorders Diffuse Alveolar Hemorrhage	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations BK Virus Associated Hemorrhagic Cystitis	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Adenovirus Viremia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations HSV Viremia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Pseudomonas Aeruginosa Infection	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Varicella Zoster	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Gastrointestinal GvHD	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Clostridium Difficile	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
General disorders Pansinusitis	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Renal and urinary disorders Renal Insufficiency	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Enterococcus/ASTR Sepsis	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Respiratory Syncytial Virus Upper Respiratory Illness	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Aspergillus Terreus Pneumonia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Alpha Hemolytic Strep Bacteremia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Epstein-Barr Virus Post-Transplant Lymphoproliferative Disease	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.

Other adverse events
Measure	Stem Cell Infusion n=9 participants at risk Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.	Low Dose Donor T-Cells n=3 participants at risk Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.	High Dose Donor T-Cells n=4 participants at risk Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3\10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\10/L for 3 consecutive days.
Immune system disorders Allergic Reaction due to Campath	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Cardiac disorders Atrial Flutter	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Cardiac disorders Hypertension	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Metabolism and nutrition disorders Fluid Overload	66.7% 6/9 • Number of events 6 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Diarrhea	44.4% 4/9 • Number of events 4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Mucositis	44.4% 4/9 • Number of events 4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Nausea	100.0% 9/9 • Number of events 9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	100.0% 3/3 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	100.0% 4/4 • Number of events 4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Renal and urinary disorders Tacrolimus Induced Renal Insufficiency	33.3% 3/9 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Metabolism and nutrition disorders Elevated Alanine Aminotransferase	22.2% 2/9 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Metabolism and nutrition disorders Elevated Bilirubin	44.4% 4/9 • Number of events 4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
General disorders Tacrolimus Induced Headaches	22.2% 2/9 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Pneumonia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Fungal Pneumonia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Skin and subcutaneous tissue disorders Campath Induced Hives	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Skin and subcutaneous tissue disorders Skin GvHD	55.6% 5/9 • Number of events 6 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	75.0% 3/4 • Number of events 4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Skin and subcutaneous tissue disorders Campath Induced Rash	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Gastrointestinal GvHD	22.2% 2/9 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Upper Gastrointestinal GvHD	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	75.0% 3/4 • Number of events 4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Hepatobiliary disorders Liver GvHD	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Aspirated Pneumonia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Metabolism and nutrition disorders Elevated Alkaline Phosphatase	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Cytomegalovirus Antigenemia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Skin and subcutaneous tissue disorders Fungal Dermatitis	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Gastrointestinal Bleed	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Cytomegalovirus Reactivation	33.3% 3/9 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	100.0% 3/3 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	75.0% 3/4 • Number of events 3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Skin and subcutaneous tissue disorders Viral Lesion	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Enterococcus Faecalis Bacteremia	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Adenovirus Viremia	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Eye disorders Ocular GvHD	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders HSV Oral Lesions	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Neutropenic Colitis	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Renal and urinary disorders Renal Insufficiency	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Psychiatric disorders Altered Mental Status Change	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Nervous system disorders Headaches	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Staphylococcus Epidermidis Bacteremia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Gastrointestinal disorders Clostridium Difficile Colitis	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Infections and infestations Epstein-Barr Viremia	0.00% 0/9 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.
Respiratory, thoracic and mediastinal disorders Multifocal Pneumonia	11.1% 1/9 • Number of events 1 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/3 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.	0.00% 0/4 • Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.