Trial Outcomes & Findings for Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies (NCT NCT01823198)

NCT ID: NCT01823198

Last Updated: 2023-11-07

Results Overview

Participants that experienced DLT related to the NK Cells post transplant at different dose levels.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 63 participants
• Primary outcome timeframe: Up to 42 days
• Results posted on: 2023-11-07

Participant Flow

Participants were recruited at MD Anderson Cancer Center.

Sixty three participants were enrolled in MDACC which 42 recipients and 21 related donors have signed consents. Twenty one ex-vivo NK cell derived from cord blood are from MDACC cord blood bank.

Participant milestones

Measure	Phase I: NK Cell Dose Level 1_10^6 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	Phase II: NK Cell Dose Level 3_3x10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	Donors Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
Overall Study STARTED	6	6	4	4	1	21	21
Overall Study COMPLETED	6	5	4	4	1	18	18
Overall Study NOT COMPLETED	0	1	0	0	0	3	3

Reasons for withdrawal

Measure	Phase I: NK Cell Dose Level 1_10^6 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	Phase II: NK Cell Dose Level 3_3x10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	Donors Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
Overall Study Physician Decision	0	1	0	0	0	3	3

Baseline Characteristics

Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies

Baseline characteristics by cohort

Measure	Phase I: NK Cell Dose Level 1_10^6 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 3_3x10^7 n=1 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 n=21 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	Donors n=21 Participants Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	20 Participants n=8 Participants	21 Participants n=8 Participants	62 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants	12 Participants n=8 Participants	28 Participants n=24 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	16 Participants n=8 Participants	9 Participants n=8 Participants	35 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	6 Participants n=8 Participants	16 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	17 Participants n=8 Participants	15 Participants n=8 Participants	47 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	1 participants n=21 Participants	21 participants n=8 Participants	21 participants n=8 Participants	63 participants n=24 Participants

PRIMARY outcome

Timeframe: Up to 42 days

Population: Twenty one donor participants were not included in outcome analysis.

Participants that experienced DLT related to the NK Cells post transplant at different dose levels.

Outcome measures

Measure	Phase I: NK Cell Dose Level 1_10^6 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 3_3x10^7 n=1 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 n=21 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood
Number of Participants Who Experienced Dose-limiting Toxicities (DLT) Group A: NK cells from KIR mismatched haplo donors	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Dose-limiting Toxicities (DLT) Group B: NK cells from KIR mismatched cord blood donors	2 Participants	2 Participants	2 Participants	2 Participants	1 Participants	12 Participants
Number of Participants Who Experienced Dose-limiting Toxicities (DLT) Group C: NK cells from matched related donors	2 Participants	3 Participants	2 Participants	2 Participants	0 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Twenty one donor participants were not included in outcome analysis.

Participants that survived between day of transplant and day of death on different dose levels.

Outcome measures

Measure	Phase I: NK Cell Dose Level 1_10^6 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 3_3x10^7 n=1 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 n=21 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood
Overall Survival Group C: NK cells from matched related donors	2 Participants	0 Participants	3 Participants	2 Participants	0 Participants	2 Participants
Overall Survival Group A: NK cells from KIR mismatched haplo donors	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Overall Survival Group B: NK cells from KIR mismatched cord blood donors	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to day 42

Population: Twenty one donor participants were not included in outcome analysis.

Number of participants that had grade 3 toxicities up to day 42.

Outcome measures

Measure	Phase I: NK Cell Dose Level 1_10^6 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 n=6 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 n=4 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 3_3x10^7 n=1 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 n=21 Participants Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood
Number of Participants With Grade 3 Toxicities Group C: NK cells from matched related donors	2 Participants	2 Participants	2 Participants	2 Participants	0 Participants	6 Participants
Number of Participants With Grade 3 Toxicities Group A: NK cells from KIR mismatched haplo donors	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade 3 Toxicities Group B: NK cells from KIR mismatched cord blood donors	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	11 Participants

Adverse Events

Phase I: NK Cell Dose Level 1_10^6

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase I: NK Cell Dose Level 2_10^7

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Phase I: NK Cell Dose Level 3_ 3x10^7

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Phase I: NK Cell Dose Level 4_ 10^8

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

Phase II: NK Cell Dose Level 3_3x10^7

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase II: NK Cell Dose Level 4_ 10^8

Serious events: 6 serious events

Other events: 17 other events

Deaths: 9 deaths

Donors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase I: NK Cell Dose Level 1_10^6 n=6 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 n=6 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 n=4 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 n=4 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 3_3x10^7 n=1 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 n=21 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	Donors Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
Infections and infestations Viral Infections	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Respiratory, thoracic and mediastinal disorders Chronic lung GvHD	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Blood and lymphatic system disorders Secondary graft failure	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Infections and infestations Fungal Infections	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Hepatobiliary disorders Liver GvHD	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	14.3% 3/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders GI GvHD	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Skin and subcutaneous tissue disorders Chronic Skin GvHD	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Infections and infestations Bacterial Infections	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.

Other adverse events

Measure	Phase I: NK Cell Dose Level 1_10^6 n=6 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 2_10^7 n=6 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 3_ 3x10^7 n=4 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase I: NK Cell Dose Level 4_ 10^8 n=4 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 3_3x10^7 n=1 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	Phase II: NK Cell Dose Level 4_ 10^8 n=21 participants at risk Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	Donors Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 3/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	9.5% 2/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	23.8% 5/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Skin and subcutaneous tissue disorders Skin GvHD	50.0% 3/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 3/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	75.0% 3/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	47.6% 10/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders Upper GI GvHD	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	19.0% 4/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Infections and infestations Viral Infections	66.7% 4/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 7/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Investigations ABO incompatibility	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Immune system disorders Allergic reaction	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Infections and infestations Bacterial Infections	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 7/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Infections and infestations BK virus associated hemorrhagic cystitis	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	23.8% 5/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Respiratory, thoracic and mediastinal disorders Bronchiolitis obliterans with organizing pneumonia	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Investigations Chronic Liver GvHD	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Eye disorders Chronic ocular GvHD	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 7/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders Chronic oral GvHD	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	28.6% 6/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Skin and subcutaneous tissue disorders Chronic Skin GvHD	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Reproductive system and breast disorders Chronic vaginal GvHD	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Investigations Creatinine increased	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	9.5% 2/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	75.0% 3/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	47.6% 10/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Nervous system disorders Dizziness	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	14.3% 3/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Cardiac disorders Ejection fraction decreased	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Investigations Elevated bilirubin	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 3/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	38.1% 8/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Investigations Elevated transminitis	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	28.6% 6/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
General disorders Fevers	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 3/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	75.0% 3/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	19.0% 4/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
General disorders Flu like syndrome	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
General disorders Fluid overload	66.7% 4/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	75.0% 3/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	42.9% 9/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Infections and infestations Fungal Infections	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders GI GvHD	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	23.8% 5/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Nervous system disorders Headache	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	14.3% 3/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Vascular disorders Hypertension	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	16.7% 1/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	14.3% 3/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Investigations Idiopathic thrombocytopenic purpura (ITP)	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	4.8% 1/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders Liver GvHD	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	9.5% 2/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders Mucositis	100.0% 6/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	83.3% 5/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 4/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 4/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	81.0% 17/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Gastrointestinal disorders Nausea	100.0% 6/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	83.3% 5/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	75.0% 3/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 4/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	100.0% 1/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	81.0% 17/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.
Blood and lymphatic system disorders Neutropenic fevers	50.0% 3/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 2/6 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	50.0% 2/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	25.0% 1/4 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	0.00% 0/1 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	33.3% 7/21 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.	— 0/0 • Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years). Donor participants only signed the consents and were not part of the results and Adverse events were not collected.

Additional Information

Richard Champlin, MD / Stem Cell Transplantation Department

University of Texas MD Anderson Cancer Center

Phone: 713-792-3618

Email: rchampli@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place