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NCT02790515 · ClinicalTrials.gov registry record · Phase 2
Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation
A Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
- 1
- Study location
NCT02790515 is a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 170 participants, above the 140-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (21% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02790515, a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
- 1
- Study location
Study Summary
This study seeks to examine treatment therapy that will reduced regimen-related toxicity and relapse while promoting rapid immune reconstitution with limited serious graft-versus-host-disease (GVHD) and also improve disease-free survival and quality of life. The investigators propose to evaluate the safety and efficacy of selective naive T-cell depleted (by TCRɑβ and CD45RA depletion, respectively) haploidentical hematopoietic cell transplant (HCT) following reduced intensity conditioning regimen that avoids radiation in patients with hematologic malignancies that have relapsed or are refractory following prior allogeneic transplantation. PRIMARY OBJECTIVE: * To estimate engraftment by day +30 post-transplant in patients who receive TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen without radiation. SECONDARY OBJECTIVES: * Assess the safety and feasibility of the addition of Blinatumomab in the early post-engraftment period in patients with CD19+ malignancy. * Estimate the incidence of malignant relapse, event-free survival, and 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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG G-CSF
- DRUG Blinatumomab
- DRUG Anti-thymocyte globulin (rabbit)
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2016-07-14 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02790515
The ClinicalTrials.gov registry entry for NCT02790515 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 140-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (21% higher). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02790515 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT02790515 about?
NCT02790515 is a clinical study titled "Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation". This study seeks to examine treatment therapy that will reduced regimen-related toxicity and relapse while promoting rapid immune reconstitution with limited serious graft-versus-host-disease (GVHD) and also improve disease-free survival and quality of life. The investigators propose to evaluate the...
What is the current status of trial NCT02790515?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2016-07-14. Estimated completion is 2026-07-01.
What conditions does trial NCT02790515 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Acute Lymphoblastic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Non Hodgkin Lymphoma (NHL).
What interventions are being tested in trial NCT02790515?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), G-CSF (DRUG), Blinatumomab (DRUG), Anti-thymocyte globulin (rabbit) (DRUG).
Who is sponsoring clinical trial NCT02790515?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02790515 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Acute Myeloid Leukemia (AML)
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Myelodysplastic Syndrome (MDS)
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.