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NCT03849651 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Hodgkin Lymphoma and Acute Myeloid Leukemia (AML), sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT03849651: Active Phase 2 study of Hodgkin Lymphoma and Acute Myeloid Leukemia (AML), sponsored by St. Jude Children's Research Hospital.
NCT03849651 is a Phase 2 study of Hodgkin Lymphoma and Acute Myeloid Leukemia (AML) that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 69 participants, below the 165-participant average among 71 other Hodgkin Lymphoma trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03849651, a Phase 2 study of Hodgkin Lymphoma and Acute Myeloid Leukemia (AML), is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Melphalan
- DRUG Thiotepa
- BIOLOGICAL Fludarabine
- BIOLOGICAL G-csf
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2026-06-07 |
| Phase | Phase 2 |
What the registry record for NCT03849651 still lists
NCT03849651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 165-participant average among 71 other Hodgkin Lymphoma trials with a reported enrollment target (58% lower).
The record links to 8 conditions, with Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03849651 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03849651 about?
NCT03849651 is a clinical study titled "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". 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 no...
What is the current status of trial NCT03849651?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2019-01-31. Estimated completion is 2026-06-07.
What conditions does trial NCT03849651 study?
This clinical trial studies the following conditions: Hodgkin Lymphoma, Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndromes (MDS), Chronic Myeloid Leukemia (CML).
What interventions are being tested in trial NCT03849651?
The interventions under investigation include: Cyclophosphamide (DRUG), Melphalan (DRUG), Thiotepa (DRUG), Fludarabine (BIOLOGICAL), G-csf (BIOLOGICAL).
Who is sponsoring clinical trial NCT03849651?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03849651 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03849651's enrollment target sits among peer trials
69 31st of 71 higher than 41 of 71 other Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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