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NCT01690520 · ClinicalTrials.gov registry record · Phase 2
Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes
A Phase 2 study, sponsored by Nohla Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
NCT01690520: Completed Phase 2 study, sponsored by Nohla Therapeutics.
NCT01690520 is a Phase 2 study that has completed, run by Nohla Therapeutics. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01690520, a Phase 2 study, has completed, sponsored by Nohla Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well donor umbilical cord blood transplant with or without ex-vivo expanded cord blood progenitor cells works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's cells. When the healthy stem cells and ex-vivo expanded cord blood progenitor cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expanded cord blood progenitor cells is more effective than giving a donor umbilical cord blood transplant alone.
Primary Outcome
First of two consecutive days with absolute neutrophil count (ANC) equal to or greater than 500 cell/microliter measured from day of transplant.
Interventions
- DRUG Cyclophosphamide
- DRUG Mycophenolate Mofetil
- DRUG Fludarabine Phosphate
- DRUG Cyclosporine
- BIOLOGICAL Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2012-12-11 |
| Est. Completion | 2020-05-29 |
| Phase | Phase 2 |
What the finished NCT01690520 record still lists
NCT01690520 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01690520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01690520 about?
NCT01690520 is a clinical study titled "Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes". This randomized phase II trial studies how well donor umbilical cord blood transplant with or without ex-vivo expanded cord blood progenitor cells works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes. Giving ...
What is the current status of trial NCT01690520?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2012-12-11. Estimated completion is 2020-05-29.
What interventions are being tested in trial NCT01690520?
The interventions under investigation include: Cyclophosphamide (DRUG), Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Cyclosporine (DRUG), Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT01690520?
This trial is sponsored by Nohla Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01690520's enrollment target sits among peer trials
163 418th of 2000 higher than 1,583 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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