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NCT02424968 · ClinicalTrials.gov registry record · Phase 2
CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma
A Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by Robert Lowsky.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02424968: Completed Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by Robert Lowsky.
NCT02424968 is a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia that has completed, run by Robert Lowsky. The registered enrollment target is 18 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02424968, a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, has completed, sponsored by Robert Lowsky.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase 2 trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and anti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells, such as CD8+ memory T-cells, may boost this effect and may be an effective treatment to kill any cancer cells that may be left in the body (consolidative therapy).
Primary Outcome
A measure of success for the therapeutic infusion of allogeneic transplantation of cluster of differentiation 8 (CD8+) memory T-cells is full-dose donor chimerism (FDC). This means to achieve ≥ 95% donor cells in either the CD3+ blood cell lineage or whole blood, within 90 days of the allogeneic CD8+ memory T-cell infusion. The outcome is reported as the number of participants that achieve FDC within 90 days, a number without dispersion.
Conditions Studied
Interventions
- BIOLOGICAL Anti-Thymocyte Globulin
- DRUG Mycophenolate Mofetil
- DRUG Cyclosporine
- PROCEDURE Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant
- BIOLOGICAL Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells
Study Locations (1)
California
- Stanford University, School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-06 |
| Est. Completion | 2021-04 |
| Phase | Phase 2 |
What the finished NCT02424968 record still lists
NCT02424968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Anti-Thymocyte Globulin is the first listed.
NCT02424968 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02424968 about?
NCT02424968 is a clinical study titled "CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma". This phase 2 trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and anti-thymocyte globulin befor...
What is the current status of trial NCT02424968?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2015-06. Estimated completion is 2021-04.
What conditions does trial NCT02424968 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome, Hodgkin Lymphoma, Myeloproliferative Neoplasm.
What interventions are being tested in trial NCT02424968?
The interventions under investigation include: Anti-Thymocyte Globulin (BIOLOGICAL), Mycophenolate Mofetil (DRUG), Cyclosporine (DRUG), Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant (PROCEDURE), Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02424968?
This trial is sponsored by Robert Lowsky, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02424968 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02424968's enrollment target sits among peer trials
18 259th of 306 higher than 40 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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