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NCT02105766 · ClinicalTrials.gov registry record · Phase 2
Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure
A Phase 2 study of Sickle Cell Disease and Graft Vs Host Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Active
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT02105766 is a Phase 2 study of Sickle Cell Disease and Graft Vs Host Disease that is active but no longer recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 56 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02105766, a Phase 2 study of Sickle Cell Disease and Graft Vs Host Disease, is active but no longer recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Some sickle cell disease or beta-thalassemia can be cured with transplant. Researchers want to test a variation of transplant that uses low dose radiation and a combination of immunosuppressive drugs. They want to know if it helps a body to better accept donor stem cells. Objectives: \- To see if low dose radiation (300 rads), oral cyclophosphamide, pentostatin, and sirolimus help a body to better accept donor stem cells. Eligibility: \- People 4 and older with beta-thalassemia or sickle cell disease that can be cured with transplant, and their donors. Design: * Participants and donors will be screened with medical history, physical exam, blood test, tissue and blood typing, and bone marrow sampling. They will visit a social worker. * Donors: * may receive an intravenous (IV) tube in their groin vein. * will receive a drug injection daily for 5 or 6 days to move the blood stem cells from the bone marrow into general blood circulation. * will undergo apheresis: an IV is put into a vein in each arm. Blood is taken from one arm, a machine removes the white blood cells that contain blood stem cells, and the rest is returned through the other arm. * Participants: * may undergo red cell exchange procedure. * will remain in the hospital for about 30 days. * will receive a large IV line that can stay in their body from transplant through recovery. * will receive a dose of radiation, and transplant related drugs by mouth or IV. * will receive blood stem cells over 8 hours by IV. * will take neuropsychological tests and may complete questionnaires throughout the transplant process. * must stay near NIH for 4 months. They will visit the outpatient clinic weekly.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Sirolimus
- DRUG Alemtuzumab
- DRUG Pentostatin
- PROCEDURE Radiotherapy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2014-04-21 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02105766
The ClinicalTrials.gov registry entry for NCT02105766 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (81% 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 4 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02105766 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02105766 about?
NCT02105766 is a clinical study titled "Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure". Background: \- Some sickle cell disease or beta-thalassemia can be cured with transplant. Researchers want to test a variation of transplant that uses low dose radiation and a combination of immunosuppressive drugs. They want to know if it helps a body to better accept donor stem cells. Objectives...
What is the current status of trial NCT02105766?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2014-04-21. Estimated completion is 2027-12-31.
What conditions does trial NCT02105766 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Graft Vs Host Disease, Thalassemia, Stem Cell Transplantation.
What interventions are being tested in trial NCT02105766?
The interventions under investigation include: Cyclophosphamide (DRUG), Sirolimus (DRUG), Alemtuzumab (DRUG), Pentostatin (DRUG), Radiotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT02105766?
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 NCT02105766 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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