Trial · NCT03849651

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

NCT03849651, Phase 2, Active not recruiting, St. Jude Children's Research Hospital; results first posted 2026-03-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT03849651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03849651

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT03849651
Status: Active not recruiting
Phases: Phase 2
Enrollment: 69 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), NK-Cell Leukemia, Hodgkin Lymphoma, Non Hodgkin Lymphoma (NHL), Juvenile Myelomonocytic Leukemia (JMML), Chronic Myeloid Leukemia (CML)
Interventions: Cyclophosphamide, Fludarabine, Thiotepa, Melphalan, G-csf, Mesna, CliniMACS, ATG (rabbit), Blinatumomab, TCRα/β+, CD19+, CD45RA-depleted DLI
First posted: 2019-02-21
Last updated: 2026-09-15
Results first posted: 2026-03-04

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Effective Dose for Prophylactic CD45RA-depleted DLI	4 weeks post-DLI (up to approximately 12 weeks post-transplant)	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.
Primary	One-year Event Free Survival (EFS) After Completion of the Protocol	One year after receiving transplant	Kaplan-Meier estimate of the percentage of being alive and relapse free one year after the date of transplant. (Events=relapse, death)
Secondary	The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity	28 days after receiving first dose of Blinatumomab (up to approximately 7 months post-transplant)	If the drug is held for more than 2 weeks due to toxicity, it will be permanently discontinued
Secondary	The Estimate of Cumulative Incidence of Relapse	1 year after receiving transplant]	Kalbfleisch and Prentice estimate of the percentage of experiencing relapse one year after the date of transplant. (Events=relapse, competing events=death)
Secondary	The Estimate of Overall Survival	One year after receiving transplant	Kaplan-Meier estimate of the percentage of experiencing death one year after the date of transplant. (Events=death)
Secondary	The Cumulative Incidence of Any Severity Chronic Graft-Versus-Host Disease (GVHD)	One year after receiving 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."
Secondary	The Cumulative Incidence of Any Grade Acute Graft-Versus-Host Disease (GVHD)	One year after receiving 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."
Secondary	The Cumulative Incidence of Transplant Related Mortality	100 days after receiving transplant	Kalbfleisch and Prentice estimate of the percentage of experiencing TRM 100 days after the date of transplant. (Events=TRM, competing events=relapse)

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Effective Dose for Prophylactic CD45RA-depleted DLI	4 weeks post-DLI (up to approximately 12 weeks post-transplant)	Patients who met eligibility criteria and received transplant during the dose-finding phase.	cells/kg	NUMBER
PRIMARY	One-year Event Free Survival (EFS) After Completion of the Protocol	One year after receiving transplant	Patients who met eligibility criteria and received transplant.	percentage of participants	NUMBER
SECONDARY	The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity	28 days after receiving first dose of Blinatumomab (up to approximately 7 months post-transplant)	Patients who met eligibility criteria, received transplant, and received blinatumomab.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Estimate of Cumulative Incidence of Relapse	1 year after receiving transplant]	Patients who met eligibility criteria and received transplant.	percentage of participants	NUMBER
SECONDARY	The Estimate of Overall Survival	One year after receiving transplant	Patients who met eligibility criteria and received transplant.	percentage of participants	NUMBER
SECONDARY	The Cumulative Incidence of Any Severity Chronic Graft-Versus-Host Disease (GVHD)	One year after receiving transplant	Patients who met eligibility criteria and received transplant.	percentage of participants	NUMBER
SECONDARY	The Cumulative Incidence of Any Grade Acute Graft-Versus-Host Disease (GVHD)	One year after receiving transplant	Patients who met eligibility criteria and received transplant.	percentage of participants	NUMBER
SECONDARY	The Cumulative Incidence of Transplant Related Mortality	100 days after receiving transplant	Patients who met eligibility criteria and received transplant.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Effective Dose for Prophylactic CD45RA-depleted DLI	Dose Finding Transplant Participants	100000000		cells/kg
One-year Event Free Survival (EFS) After Completion of the Protocol	All Transplant Participants	73.9	95% Confidence Interval 61.8 to 82.7	percentage of participants
One-year Event Free Survival (EFS) After Completion of the Protocol	Dose 1	66.7	95% Confidence Interval 28.2 to 87.8	percentage of participants
One-year Event Free Survival (EFS) After Completion of the Protocol	Dose 2	60.0	95% Confidence Interval 25.3 to 82.7	percentage of participants
One-year Event Free Survival (EFS) After Completion of the Protocol	Dose 3	70.0	95% Confidence Interval 32.9 to 89.2	percentage of participants
One-year Event Free Survival (EFS) After Completion of the Protocol	Phase 2	80.0	95% Confidence Interval 64.0 to 89.5	percentage of participants
The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity	All Transplant Participants	3		Participants
The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity	Dose 1	0		Participants
The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity	Dose 2	0		Participants
The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity	Dose 3	1		Participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dose Level 1 Transplant Participants	9
Overall Study	STARTED	Dose Level 2 Transplant Participants	10
Overall Study	STARTED	Dose Level 3 Transplant Participants	10
Overall Study	STARTED	Phase 2 Transplant Participants	40
Overall Study	COMPLETED	Dose Level 1 Transplant Participants	9
Overall Study	COMPLETED	Dose Level 2 Transplant Participants	10
Overall Study	COMPLETED	Dose Level 3 Transplant Participants	10
Overall Study	COMPLETED	Phase 2 Transplant Participants	38
Overall Study	NOT COMPLETED	Dose Level 1 Transplant Participants	0
Overall Study	NOT COMPLETED	Dose Level 2 Transplant Participants	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events112

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	Dose 1	0	9	0
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	Dose 2	0	10	0
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	Dose 3	2	10	2
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	Phase 2	4	40	4
other	Febrile neutropenia	Blood and lymphatic system disorders	Dose 1	8	9	8
other	Febrile neutropenia	Blood and lymphatic system disorders	Dose 2	7	10	7
other	Febrile neutropenia	Blood and lymphatic system disorders	Dose 3	7	10	7
other	Febrile neutropenia	Blood and lymphatic system disorders	Phase 2	32	40	32
other	Mucositis oral	Gastrointestinal disorders	Dose 1	8	9	8
other	Mucositis oral	Gastrointestinal disorders	Dose 2	9	10	9

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dose 1	2	9
Total, all-cause mortality	Dose 2	2	10
Total, all-cause mortality	Dose 3	1	10
Total, all-cause mortality	Phase 2	6	40
Total, other adverse events	Dose 1	9	9
Total, other adverse events	Dose 2	10	10
Total, other adverse events	Dose 3	10	10
Total, other adverse events	Phase 2	40	40
Total, serious adverse events	Dose 1	6	9
Total, serious adverse events	Dose 2	7	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03849651

GET https://conductscience.org/api/trials/v1/NCT03849651/results?page=2

API reference For AI assistants