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NCT01866839 · ClinicalTrials.gov registry record · Phase 1
Preventing Stem Cell Transplant Complications With a Blood Separator Machine
A Phase 1 study of Lymphoma, Non-Hodgkin and MDS (Myelodysplastic Syndrome), sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT01866839: Completed Phase 1 study of Lymphoma, Non-Hodgkin and MDS (Myelodysplastic Syndrome), sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01866839 is a Phase 1 study of Lymphoma, Non-Hodgkin and MDS (Myelodysplastic Syndrome) that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 41 participants, below the 389-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01866839, a Phase 1 study of Lymphoma, Non-Hodgkin and MDS (Myelodysplastic Syndrome), has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Researchers are working to make stem cell transplant procedures safer and more effective. One complication of transplants is graft-versus-host disease (GVHD). This complication happens when certain white blood cells from the donor attack the recipient's own body. Researchers want to test a blood separator machine that may help remove more of the donor's white blood cells before transplant. They will study donors and recipients during stem cell transplant to see how well this process can prevent GVHD and other complications. Objectives: \- To see if a new blood separator machine can improve outcomes of stem cell transplants. Eligibility: * Individuals between 10 and 75 years of age who are having a stem cell transplant for leukemia or other blood-related cancers. * Donors for the stem cell transplant. Design: * Recipients and donors will be screened with a physical exam and medical history. * Donors will have two blood collection procedures. The first will collect only white blood cells, and return the rest of the blood. After the first collection, participants will have filgrastim injections to help their stem cells enter their blood. Then, they will have a second blood collection for the stem cells. * Recipients will have radiation and chemotherapy to prepare for the stem cell transplant. They will then have the stem cell transplant with the donor cells that have been treated with the blood separator machine. * Recipients will be monitored closely after the procedure. They may receive some of their donor's white blood cells if needed to fight serious infections. * Recipients will have the regular standard of care after their transplant. Blood samples will be taken and any side effects will be monitored and treated.
Primary Outcome
Determine the rate of overall survival at 200 day
Conditions Studied
Interventions
- DEVICE Graft Manipulation (CD34+ Selection)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-05-29 |
| Est. Completion | 2018-06-28 |
| Phase | Phase 1 |
What the finished NCT01866839 record still lists
NCT01866839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 389-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 1 intervention - of which Graft Manipulation (CD34+ Selection) is the first listed.
NCT01866839 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01866839 about?
NCT01866839 is a clinical study titled "Preventing Stem Cell Transplant Complications With a Blood Separator Machine". Background: \- Researchers are working to make stem cell transplant procedures safer and more effective. One complication of transplants is graft-versus-host disease (GVHD). This complication happens when certain white blood cells from the donor attack the recipient's own body. Researchers want to ...
What is the current status of trial NCT01866839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2013-05-29. Estimated completion is 2018-06-28.
What conditions does trial NCT01866839 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin, MDS (Myelodysplastic Syndrome), Myeloproliferative Disorder, AML (Acute Myelogenous Leukemia), ALL (Acute B-Lymphoblastic Leukemia).
What interventions are being tested in trial NCT01866839?
The interventions under investigation include: Graft Manipulation (CD34+ Selection) (DEVICE).
Who is sponsoring clinical trial NCT01866839?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01866839 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01866839's enrollment target sits among peer trials
41 36th of 58 higher than 23 of 58 other Lymphoma, Non-Hodgkin trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, Non-Hodgkin 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.
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