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NCT00343798 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies
A Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 4
- Study locations
NCT00343798 is a Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 23 participants, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (81% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT00343798, a Phase 1 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase I multicenter feasibility trial is studying the safety and potential efficacy of infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood unit for transplantation following conditioning with fludarabine, cyclophosphamide and total body irradiation (TBI), and immunosuppression with cyclosporine and mycophenolate mofetil (MMF) for patients with hematologic malignancies. Chemotherapy, such as fludarabine and cyclophosphamide, and TBI given before an umbilical cord blood transplant stops the growth of leukemia cells and works to prevent the patient's immune system from rejecting the donor's stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red blood cells, white blood cells, and platelets. It may take several weeks for these new blood cells to grow. During that period of time, patients are at increased risk for bleeding and infection. Faster recovery of white blood cells may decrease the number and severity of infections. Studies have shown that counts are more likely to recover more quickly if increased numbers of cord blood cells are given with the transplant. We have developed a way of growing or "expanding" the number of cord blood cells in the lab so that there are more cells available for transplant. We are doing this study to find out whether or not giving these expanded cells along with one unexpanded cord blood unit is safe and if use of expanded cells can decrease the time it takes for white blood cells to recover after transplant. We will study the time it takes for blood counts to recover, which of the two cord blood units makes up the patient's new blood system, and how quickly immune system cells return
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- DRUG cyclosporine
- DRUG mycophenolate mofetil
- OTHER ex-vivo umbilical cord blood expansion
Study Locations (4)
Colorado
- University of Colorado Cancer Center - Anschutz Cancer Pavilion - Aurora
- University of Colorado - Denver
California
- City of Hope Medical Center - Duarte
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2006-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00343798
The ClinicalTrials.gov registry entry for NCT00343798 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (81% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00343798 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Colorado, California, Washington.
Frequently Asked Questions
What is clinical trial NCT00343798 about?
NCT00343798 is a clinical study titled "A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies". This phase I multicenter feasibility trial is studying the safety and potential efficacy of infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood unit for transplantation following conditioning with fludarabine, cyclophosphamide and total body irradiation (TBI)...
What is the current status of trial NCT00343798?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2006-04.
What conditions does trial NCT00343798 study?
This clinical trial studies the following conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22).
What interventions are being tested in trial NCT00343798?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), cyclosporine (DRUG), mycophenolate mofetil (DRUG), ex-vivo umbilical cord blood expansion (OTHER).
Who is sponsoring clinical trial NCT00343798?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00343798 being conducted?
This trial has 4 study locations across California, Colorado, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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