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NCT01517035 · ClinicalTrials.gov registry record · Phase 1
Improving Blood Stem Cell Collection and Transplant Procedures
A Phase 1 study of Acute Lymphoblastic Leukemia and Chronic Myelogenous Leukemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT01517035 is a Phase 1 study of Acute Lymphoblastic Leukemia and Chronic Myelogenous Leukemia that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 43 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01517035, a Phase 1 study of Acute Lymphoblastic Leukemia and Chronic Myelogenous Leukemia, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- People who have some kinds of cancer can benefit from donated bone marrow stem cells. These stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells. However, stem cells transplants do not always work. Also, they may have serious side effects that can cause illness or death. The Bone Marrow Stem Cell Transplant Program is studying methods to make stem cell transplant procedures safer and more effective. Objectives: \- To test a new procedure that may improve the success and decrease the side effects of stem cell transplants. Eligibility: * Individuals 10 to 75 years of age who have a life-threatening illness that may require a stem cell transplant. * Healthy siblings who are able to provide stem cells for transplant. Design: * Participants will be screened with a medical history, physical exam, and blood and urine tests. * Donor procedures: * Stem cell donors will start by having apheresis to donate white blood cells. * Donors will receive filgrastim shots for 5 days to help move stem cells into the blood for collection. * Donors will have another round of apheresis to donate the stem cells for transplant. * Recipient procedures: * Before the transplant, recipients will have radiation twice a day for 3 days and chemotherapy for 7 days. * After the radiation and chemotherapy, recipients will receive the stem cells provided by the donor. * After the transplant, recipients will receive the white blood cells provided by the donor. * Recipients will be monitored closely for 4 months to study the success of the transplant. They will have more followup visits at least yearly thereafter. * Recipients will have a research apheresis prior to transplant and at 3 months.
Conditions Studied
Interventions
- PROCEDURE Stem Cell Transplantation
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-01-13 |
| Est. Completion | 2017-03-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01517035
The ClinicalTrials.gov registry entry for NCT01517035 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (89% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Stem Cell Transplantation is the first listed.
NCT01517035 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01517035 about?
NCT01517035 is a clinical study titled "Improving Blood Stem Cell Collection and Transplant Procedures". Background: \- People who have some kinds of cancer can benefit from donated bone marrow stem cells. These stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells. However, stem cells transplants do not always work. Also, they may have serious side effects that can...
What is the current status of trial NCT01517035?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2012-01-13. Estimated completion is 2017-03-29.
What conditions does trial NCT01517035 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome (MDS), CLL (Chronic Lymphocytic Leukemia), CML (Chronic Myelogenous Leukemia).
What interventions are being tested in trial NCT01517035?
The interventions under investigation include: Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01517035?
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 NCT01517035 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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