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NCT03622788 · ClinicalTrials.gov registry record · Phase 1
Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell Transplant
A Phase 1 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03622788: Active Phase 1 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT03622788 is a Phase 1 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03622788, a Phase 1 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies how well cytokine-treated veto cells work in treating patients with hematologic malignancies following stem cell transplant. Giving chemotherapy and total-body irradiation before a stem 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. Cytokine-treated veto cells may help the transplanted donor cells to develop and grow in recipients without causing graft-versus-host-disease (GVHD - when transplanted donor tissue attacks the tissues of the recipient's body).
Primary Outcome
For the purpose of dose-finding, toxicity is defined as steroid resistant grade 3 or 4 graft-versus-host-disease (GVHD), or death from any cause, within 42 days of veto cell infusion.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Anti-Thymocyte Globulin
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- BIOLOGICAL Cytokine-treated Veto Cells
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-08-08 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What the registry record for NCT03622788 still lists
NCT03622788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (86% lower).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03622788 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03622788 about?
NCT03622788 is a clinical study titled "Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell Transplant". This phase I/II trial studies how well cytokine-treated veto cells work in treating patients with hematologic malignancies following stem cell transplant. Giving chemotherapy and total-body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal ...
What is the current status of trial NCT03622788?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-08-08. Estimated completion is 2027-12-01.
What conditions does trial NCT03622788 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Mantle Cell Lymphoma.
What interventions are being tested in trial NCT03622788?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Anti-Thymocyte Globulin (BIOLOGICAL), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Cytokine-treated Veto Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03622788?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03622788 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03622788's enrollment target sits among peer trials
16 269th of 306 higher than 34 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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