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NCT01175785 · ClinicalTrials.gov registry record · Phase 2
Infusion of Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant in Patients With Hematologic Malignancies
A Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Nohla Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01175785: Completed Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by Nohla Therapeutics.
NCT01175785 is a Phase 2 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 Nohla Therapeutics. The registered enrollment target is 15 participants, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01175785, a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by Nohla Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial is studying the safety and potential efficacy of infusing non-human leukocyte antigen matched ex vivo expanded cord blood progenitors with one or two unmanipulated umbilical cord blood units for transplantation following conditioning with fludarabine phosphate, cyclophosphamide and total body irradiation, and immunosuppression with cyclosporine and mycophenolate mofetil for patients with hematologic malignancies. Chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation 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 recover more quickly when more 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 or two unexpanded cord blood units 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 or three cord blood units makes up the patient's new blood system, and how quickly immune system cells return.
Primary Outcome
Defined as the first of 2 consecutive days in which the absolute neutrophil count (ANC) \>= 500.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- RADIATION total-body irradiation
- PROCEDURE umbilical cord blood transplantation
- BIOLOGICAL ex vivo-expanded cord blood progenitor cell infusion
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01175785 record still lists
NCT01175785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (87% lower).
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.
NCT01175785 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01175785 about?
NCT01175785 is a clinical study titled "Infusion of Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant in Patients With Hematologic Malignancies". This phase II trial is studying the safety and potential efficacy of infusing non-human leukocyte antigen matched ex vivo expanded cord blood progenitors with one or two unmanipulated umbilical cord blood units for transplantation following conditioning with fludarabine phosphate, cyclophosphamide a...
What is the current status of trial NCT01175785?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2010-08. Estimated completion is 2014-08.
What conditions does trial NCT01175785 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 NCT01175785?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), total-body irradiation (RADIATION), umbilical cord blood transplantation (PROCEDURE), ex vivo-expanded cord blood progenitor cell infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT01175785?
This trial is sponsored by Nohla Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01175785 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
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Where NCT01175785's enrollment target sits among peer trials
15 26th of 29 higher than 4 of 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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