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NCT03399773 · ClinicalTrials.gov registry record · Phase 2
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
A Phase 2 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT03399773 is a Phase 2 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 31 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03399773, a Phase 2 study of Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Fred Hutchinson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- RADIATION Total-Body Irradiation
- DRUG Thiotepa
- BIOLOGICAL Dilanubicel
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-05-10 |
| Est. Completion | 2027-04-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03399773
The ClinicalTrials.gov registry entry for NCT03399773 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (85% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03399773 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT03399773 about?
NCT03399773 is a clinical study titled "Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes". This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa...
What is the current status of trial NCT03399773?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2022-05-10. Estimated completion is 2027-04-02.
What conditions does trial NCT03399773 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Hematopoietic and Lymphoid Cell Neoplasm, Acute Biphenotypic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive.
What interventions are being tested in trial NCT03399773?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Total-Body Irradiation (RADIATION), Thiotepa (DRUG), Dilanubicel (BIOLOGICAL).
Who is sponsoring clinical trial NCT03399773?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03399773 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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