Trial Outcomes & Findings for TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies (NCT NCT03849651)

Last Updated: 2026-04-13

Results Overview

The maximum effective dose (MED) of CD45RA-depleted DLI, defined as the maximum value of doses that satisfy the proportion of patients with their memory T cell count measured at week 4 post-DLI more than 300/uL is more than 50% and the toxicity of grade 3-4 aGVHD is less than 20%. Dose selection used a protocol-specified algorithm.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

4 weeks post-DLI (up to approximately 12 weeks post-transplant)

Results posted on

2026-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1 Transplant Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose Level 2 Transplant Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose Level 3 Transplant Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 Transplant Participants Patients who met eligibility criteria, received transplant, and received the MED dose of 1x10\^7 cells/kg
Overall Study STARTED	9	10	10	40
Overall Study COMPLETED	9	10	10	38
Overall Study NOT COMPLETED	0	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 Transplant Participants n=9 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose Level 2 Transplant Participants n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose Level 3 Transplant Participants n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 Transplant Participants n=40 Participants Patients who met eligibility criteria, received transplant, and received the MED dose of 1x10\^7 cells/kg	Total n=69 Participants Total of all reporting groups
Age, Continuous	10.5 years n=193 Participants	9.70 years n=193 Participants	8.53 years n=386 Participants	9.35 years n=112 Participants	9.43 years n=103 Participants
Sex: Female, Male Female	5 Participants n=193 Participants	7 Participants n=193 Participants	9 Participants n=386 Participants	17 Participants n=112 Participants	38 Participants n=103 Participants
Sex: Female, Male Male	4 Participants n=193 Participants	3 Participants n=193 Participants	1 Participants n=386 Participants	23 Participants n=112 Participants	31 Participants n=103 Participants
Race/Ethnicity, Customized White	7 Participants n=193 Participants	6 Participants n=193 Participants	7 Participants n=386 Participants	25 Participants n=112 Participants	45 Participants n=103 Participants
Race/Ethnicity, Customized Black	1 Participants n=193 Participants	0 Participants n=193 Participants	3 Participants n=386 Participants	9 Participants n=112 Participants	13 Participants n=103 Participants
Race/Ethnicity, Customized Other	1 Participants n=193 Participants	4 Participants n=193 Participants	0 Participants n=386 Participants	6 Participants n=112 Participants	11 Participants n=103 Participants

PRIMARY outcome

Timeframe: 4 weeks post-DLI (up to approximately 12 weeks post-transplant)

Population: Patients who met eligibility criteria and received transplant during the dose-finding phase.

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=29 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
Maximum Effective Dose for Prophylactic CD45RA-depleted DLI	100000000 cells/kg	—	—	—	—

PRIMARY outcome

Timeframe: One year after receiving transplant

Population: Patients who met eligibility criteria and received transplant.

Kaplan-Meier estimate of the percentage of being alive and relapse free one year after the date of transplant. (Events=relapse, death)

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=69 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 n=9 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=40 Participants Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
One-year Event Free Survival (EFS) After Completion of the Protocol	73.9 percentage of participants Interval 61.8 to 82.7	66.7 percentage of participants Interval 28.2 to 87.8	60.0 percentage of participants Interval 25.3 to 82.7	70.0 percentage of participants Interval 32.9 to 89.2	80.0 percentage of participants Interval 64.0 to 89.5

SECONDARY outcome

Timeframe: 28 days after receiving first dose of Blinatumomab (up to approximately 7 months post-transplant)

Population: Patients who met eligibility criteria, received transplant, and received blinatumomab.

If the drug is held for more than 2 weeks due to toxicity, it will be permanently discontinued

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=26 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 n=5 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=3 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=8 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=10 Participants Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity	3 Participants	0 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year after receiving transplant]

Population: Patients who met eligibility criteria and received transplant.

Kalbfleisch and Prentice estimate of the percentage of experiencing relapse one year after the date of transplant. (Events=relapse, competing events=death)

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=69 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 n=9 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=40 Participants Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
The Estimate of Cumulative Incidence of Relapse	23.2 percentage of participants Interval 14.0 to 33.7	33.3 percentage of participants Interval 6.7 to 64.0	30.0 percentage of participants Interval 6.1 to 59.5	30.0 percentage of participants Interval 6.2 to 59.3	17.5 percentage of participants Interval 7.6 to 30.8

SECONDARY outcome

Timeframe: One year after receiving transplant

Population: Patients who met eligibility criteria and received transplant.

Kaplan-Meier estimate of the percentage of experiencing death one year after the date of transplant. (Events=death)

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=69 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 n=9 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=40 Participants Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
The Estimate of Overall Survival	84.1 percentage of participants Interval 73.1 to 90.8	77.8 percentage of participants Interval 36.5 to 93.9	80.0 percentage of participants Interval 40.9 to 94.6	90.0 percentage of participants Interval 47.3 to 98.5	85.0 percentage of participants Interval 69.6 to 93.0

SECONDARY outcome

Timeframe: One year after receiving transplant

Population: Patients who met eligibility criteria and received transplant.

Kalbfleisch and Prentice estimate of the percentage of experiencing any severity chronic GVHD one year after the date of transplant. (Events=chronic GVHD, competing events=death) Groups with insufficient events for confidence interval estimation have confidence intervals written as "NA to NA."

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=69 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 n=9 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=40 Participants Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
The Cumulative Incidence of Any Severity Chronic Graft-Versus-Host Disease (GVHD)	4.3 percentage of participants Interval 1.1 to 11.1	0 percentage of participants No patients experienced outcome, so confidence interval is not applicable"?	10.0 percentage of participants Interval 0.4 to 37.6	10.0 percentage of participants Interval 0.5 to 37.4	2.5 percentage of participants Interval 0.2 to 11.4

SECONDARY outcome

Timeframe: One year after receiving transplant

Population: Patients who met eligibility criteria and received transplant.

Kalbfleisch and Prentice estimate of the percentage of experiencing any grade acute GVHD one year after the date of transplant. (Events=acute GVHD, competing events=death) Groups with insufficient events for confidence interval estimation have confidence intervals written as "NA to NA."

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=69 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 n=9 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=40 Participants Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
The Cumulative Incidence of Any Grade Acute Graft-Versus-Host Disease (GVHD)	27.5 percentage of participants Interval 17.6 to 38.4	0 percentage of participants No patients experienced outcome, so confidence interval is not applicable"?	50.0 percentage of participants Interval 16.3 to 76.8	30.0 percentage of participants Interval 6.2 to 59.3	27.5 percentage of participants Interval 14.7 to 41.9

SECONDARY outcome

Timeframe: 100 days after receiving transplant

Population: Patients who met eligibility criteria and received transplant.

Kalbfleisch and Prentice estimate of the percentage of experiencing TRM 100 days after the date of transplant. (Events=TRM, competing events=relapse)

Outcome measures

Outcome measures
Measure	Dose Finding Transplant Participants n=69 Participants Patients who met eligibility criteria and received transplant during the dose-finding phase.	Dose 1 n=9 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=10 Participants Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=40 Participants Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
The Cumulative Incidence of Transplant Related Mortality	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

Dose 1

Serious events: 6 serious events

Other events: 9 other events

Deaths: 2 deaths

Dose 2

Serious events: 7 serious events

Other events: 10 other events

Deaths: 2 deaths

Dose 3

Serious events: 6 serious events

Other events: 10 other events

Deaths: 1 deaths

Phase 2

Serious events: 25 serious events

Other events: 40 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Dose 1 n=9 participants at risk Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg	Dose 2 n=10 participants at risk Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg	Dose 3 n=10 participants at risk Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg	Phase 2 n=40 participants at risk Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
Blood and lymphatic system disorders Febrile neutropenia	22.2% 2/9 • Number of events 2 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	20.0% 2/10 • Number of events 2 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	0.00% 0/10 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	12.5% 5/40 • Number of events 5 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description
General disorders Fever	0.00% 0/9 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	20.0% 2/10 • Number of events 2 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	20.0% 2/10 • Number of events 2 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	17.5% 7/40 • Number of events 7 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description
Immune system disorders Immune system disorders-Other, specify	0.00% 0/9 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	10.0% 1/10 • Number of events 1 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	10.0% 1/10 • Number of events 1 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	12.5% 5/40 • Number of events 5 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description
Infections and infestations Enterocolitis	11.1% 1/9 • Number of events 1 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	10.0% 1/10 • Number of events 1 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	0.00% 0/10 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	12.5% 5/40 • Number of events 5 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description
Infections and infestations Infections and infestations - Other, specify	22.2% 2/9 • Number of events 2 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	20.0% 2/10 • Number of events 10 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	10.0% 1/10 • Number of events 1 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	5.0% 2/40 • Number of events 2 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description
Infections and infestations Sepsis	11.1% 1/9 • Number of events 1 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	10.0% 1/10 • Number of events 1 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	20.0% 2/10 • Number of events 2 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	17.5% 7/40 • Number of events 7 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description
Infections and infestations Skin infection	0.00% 0/9 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	0.00% 0/10 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	0.00% 0/10 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description	15.0% 6/40 • Number of events 6 • Adverse events were collected from the start of conditioning through one year after transplant date Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description

Other adverse events

Additional Information

Brandon Triplett, MD

St. Jude Children's Research Hospital

Phone: 8662785833

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place