TriangleNCT03849651 · STUDY IN CONTEXT
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 Transplan
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Kaplan-Meier estimate of the percentage of being alive and relapse free one year after the date of transplant. (Events=relapse, death)
If the drug is held for more than 2 weeks due to toxicity, it will be permanently discontinued
Kalbfleisch and Prentice estimate of the percentage of experiencing relapse one year after the date of transplant. (Events=relapse, competing events=death)
Kaplan-Meier estimate of the percentage of experiencing death one year after the date of transplant. (Events=death)
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."
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- trial label
- 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 Transplan
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0000
- source section id
- NCT03849651-om-0000
- source outcome index
- 0
- endpoint
- Maximum Effective Dose for Prophylactic CD45RA-depleted DLI
- endpoint definition
- 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.
- time origin
- 4 weeks post-DLI (up to approximately 12 weeks post-transplant)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who met eligibility criteria and received transplant during the dose-finding phase.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0001
- source section id
- NCT03849651-om-0001
- source outcome index
- 1
- endpoint
- One-year Event Free Survival (EFS) After Completion of the Protocol
- endpoint definition
- Kaplan-Meier estimate of the percentage of being alive and relapse free one year after the date of transplant. (Events=relapse, death)
- time origin
- One year after receiving transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who met eligibility criteria and received transplant.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0002
- source section id
- NCT03849651-om-0002
- source outcome index
- 2
- endpoint
- The Number of Patients Experiencing Blinatumomab Permanent Discontinuation Due to Toxicity
- endpoint definition
- If the drug is held for more than 2 weeks due to toxicity, it will be permanently discontinued
- time origin
- 28 days after receiving first dose of Blinatumomab (up to approximately 7 months post-transplant)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who met eligibility criteria, received transplant, and received blinatumomab.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0003
- source section id
- NCT03849651-om-0003
- source outcome index
- 3
- endpoint
- The Estimate of Cumulative Incidence of Relapse
- endpoint definition
- Kalbfleisch and Prentice estimate of the percentage of experiencing relapse one year after the date of transplant. (Events=relapse, competing events=death)
- time origin
- 1 year after receiving transplant]
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who met eligibility criteria and received transplant.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0004
- source section id
- NCT03849651-om-0004
- source outcome index
- 4
- endpoint
- The Estimate of Overall Survival
- endpoint definition
- Kaplan-Meier estimate of the percentage of experiencing death one year after the date of transplant. (Events=death)
- time origin
- One year after receiving transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who met eligibility criteria and received transplant.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0005
- source section id
- NCT03849651-om-0005
- source outcome index
- 5
- endpoint
- The Cumulative Incidence of Any Severity Chronic Graft-Versus-Host Disease (GVHD)
- endpoint definition
- 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."
- time origin
- One year after receiving transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who met eligibility criteria and received transplant.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Finding Transplant Participants
- regimen
- Patients who met eligibility criteria and received transplant during the dose-finding phase.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0001
- arm key
- OG000
- arm label
- All Transplant Participants
- regimen
- Patients who met eligibility criteria and received transplant.
- analyzed count
- 69
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose 1
- regimen
- Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Dose 2
- regimen
- Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Dose 3
- regimen
- Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Phase 2
- regimen
- Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0002
- arm key
- OG000
- arm label
- All Transplant Participants
- regimen
- Patients who met eligibility criteria and received transplant during the dose-finding phase.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose 1
- regimen
- Patients who met eligibility criteria, received transplant, received 1x10\^5 cells/kg, and received blinatumomab
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Dose 2
- regimen
- Patients who met eligibility criteria, received transplant, received 1x10\^6 cells/kg, and received blinatumomab
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Dose 3
- regimen
- Patients who met eligibility criteria, received transplant, received 1x10\^7 cells/kg, and received blinatumomab
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0002
- arm key
- OG004
- arm label
- Phase 2
- regimen
- Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0002#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Transplant Participants
- regimen
- Patients who met eligibility criteria and received transplant.
- analyzed count
- 69
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03849651-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- harm key
- EG000
- source section id
- NCT03849651-ae
- event group key
- EG000
- event group label
- Dose 1
- serious affected
- 6
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 0
- collection period
- Adverse events were collected from the start of conditioning through one year after transplant date
- event definition
- 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
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- harm key
- EG001
- source section id
- NCT03849651-ae
- event group key
- EG001
- event group label
- Dose 2
- serious affected
- 7
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Adverse events were collected from the start of conditioning through one year after transplant date
- event definition
- 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
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- harm key
- EG002
- source section id
- NCT03849651-ae
- event group key
- EG002
- event group label
- Dose 3
- serious affected
- 6
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Adverse events were collected from the start of conditioning through one year after transplant date
- event definition
- 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
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT03849651
- harm key
- EG003
- source section id
- NCT03849651-ae
- event group key
- EG003
- event group label
- Phase 2
- serious affected
- 25
- serious at risk
- 40
- other affected
- 40
- other at risk
- 40
- frequency threshold
- 0
- collection period
- Adverse events were collected from the start of conditioning through one year after transplant date
- event definition
- 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
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice