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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

StatusActive, Not Recruiting
PhasePhase 2
Started2019-01-31
View on ClinicalTrials.gov ↗

Amendment history

2026-07-01
minor
Study Status v18
Completion pushed: 2026-06-07 → 2027-12-31
2026-05-08
minor
Study Status, Adverse Events v17
Re-verified, no change to tracked fields
2026-03-23
minor
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v16
Secondary endpointsdetails revised at 2 of 6 entries
2026-02-11
minor
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v15
Completion date2025-11-07→2026-06-07
Results first postednot stated→2026-03-04
Secondary endpointsdetails revised at 1 of 6 entries
2025-10-28
minor
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v14
Secondary endpointsdetails revised at 1 of 6 entries
Show 13 earlier versions
2025-09-30
minor
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v13
Completion date2025-08-07→2025-11-07
Enrollment targetestimated 140→confirmed 69
Secondary endpoints4 to 6 entries
The numberNumber of patientsPatients experiencingExperiencing Blinatumomab permanentPermanent discontinuationDiscontinuation dueDue to toxicityToxicity The estimateEstimate of cumulativeCumulative incidenceIncidence of relapseRelapse The cumulative incidenceEstimate of acuteOverall andSurvival The chronicCumulative Incidence of Any Severity Chronic Graft-Versus-Host Disease (GVHD) The cumulativeCumulative incidenceIncidence of transplantAny relatedGrade mortalityAcute Graft-Versus-Host Disease (GVHD) The Cumulative Incidence of Transplant Related Mortality
Primary endpoints2 entries, revised
Maximum effectiveEffective doseDose for prophylacticProphylactic CD45RA-depleted DLI One-year Event Free Survival (EFS) afterAfter completionCompletion of the protocolProtocol
2025-02-21
minor
Study Status v12
Re-verified, no change to tracked fields
2024-08-16
minor
Study Status v11
Primary completion dateestimated 2024-07-01→confirmed 2024-08-07
Completion date2025-07-01→2025-08-07
2024-01-18
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2023-10-05
minor
4 amendments v6-v9
4 re-verifications since 2020-10-30, no change to tracked fields
2020-04-29
minor
Study Status, Study Description v5
Study description-9 characters
[...] tment period in patients with CD19+ malignancy Estimate the cumulative incidence of: neutrophil engraftmentand at Day +30 platelet engraftment, at Day +100 acute GVHD at Day +100 chronic GVHD at 1 year transplant related mortality (TRM) at Day +100 malignant relapse at 1 year Estimate 1yr ,event-free survival per disease subgroups (e.g. ALL vs AML) Estimate, 1yrand overall survival at one-year post-transplantation. Estimate incidence and severity of acute and chronic (GVHD). Estimate the rate of transplant related mortality (TRM) in the first 100 days after transplantation. To measure and des [...] [...]
2020-01-21
minor
2 amendments v3-v4
2 re-verifications since 2019-06-13, no change to tracked fields
2019-03-06
minor
Study Status v2
Start date2019-01-17→2019-01-31
2019-02-21
minor
Study Identification, Study Status v1
Study title-1 characters
TCRαβ-DEPLETEDdepleted PROGENITORProgenitor CELLCell GRAFTGraft WITHWith ADDITIONALAdditional MEMORYMemory T-CELLcell DLI, PLUSPlus SELECTEDSelected USEUse OFof BLINATUMOMABBlinatumomab, INin NAÏVENaive T-CELLcell DEPLETEDDepleted HAPLOIDENTICALHaploidentical DONORDonor HEMATOPOIEITCHematopoietc CELLCell TRANSPLANTATIONTransplantation FORfor HEMATOLOGICHematologic MALIGNANCIESMalignancies
2019-02-20
minor
Original filing
2,553 trials monitored
See 134 trials at risk
and 5 more diseases
Patients less than or equal to 21 years old with high-risk hematologic malignancies who would likely benefit from allogeneic hematopoietic cell transplantation (HCT). Patients with a suitable HLA matched sibling or unrelated donor identified will be eligible for participation ONLY if the donor is not available in the necessary time. The purpose of the study is to learn more about the effects (good and bad) of transplanting blood cells donated by a family member, and that have been modified in a laboratory to remove the type of T cells known to cause graft-vs.-host disease, to children and young adults with a high risk cancer that is in remission but is at high risk of relapse. This study will give donor cells that have been TCRαβ-depleted. The TCR (T-cell receptor) is a molecule that is found only on T cells. These T-cell receptors are made up of two proteins that are linked together. About 95% of all T-cells have a TCR that is composed of an alpha protein linked to a beta protein, and these will be removed. This leaves only the T cells that have a TCR made up of a gamma protein linked to a delta protein. This donor cell infusion will be followed by an additional infusion of donor memory cells (CD45RA-depleted) after donor cell engraftment. This study will be testing the safety and effects of the chemotherapy and the donor blood cell infusions on the transplant recipient's disease and overall survival.
Trial Details
NCT Number NCT03849651
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)
Enrollment 69 participants
Start Date 2019-01-31
Primary Completion 2024-08-07 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15