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Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 194 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 12 versions Re-verified since Jun 5, 2024, no change to tracked fieldsv183-v194
  2. Primary completion date: Dec 30, 2024 to Jan 30, 2030
    • Study completion date: Jan 1, 2030 to Dec 1, 2037
    v182
  3. 2 versions Re-verified since Mar 1, 2024, no change to tracked fieldsv180-v181
  4. Primary completion date: Jan 30, 2024 to Dec 30, 2024v179
  5. 2 versions Re-verified since Dec 29, 2023, no change to tracked fieldsv177-v178
Show 32 earlier versionsHide 32 earlier versions
  1. Enrollment target: 30 to 32v176
  2. Eligibility criteria expanded, about 34 words
    • Study description revised
    v175
  3. 30 versions Re-verified since Jun 2, 2022, no change to tracked fieldsv145-v174
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Sickle cell disease can often be treated with blood stem cell transplants. But for some people the disease returns. This study will give a second transplant to people whose disease has returned but still have some donor cells in their body. Objective: To cure people s sickle cell disease by giving a second treatment that makes more room in their bone marrow for donor cells. Eligibility: People ages 4 and older with sickle cell disease who had a transplant but the disease returned, and their donor relatives. Donors can be 2 years of age or older. Design: Participants will be screened with medical history, physical exam, and blood tests. Recipients will also be screened with heart and breathing tests, x-rays, a bone marrow sample, and teeth and eye exams. They must have a caregiver. Donors will have 7-8 visits. They will take a drug for 5-6 days to prepare them for the donation. For the donation, blood is taken from a vein in the arm or groin. The stem cells are collected. The rest of the blood is returned. This may be repeated. Recipients will get a long IV line in their arm or chest for about 1-2 months. They will take drugs to help their body accept the donor cells. They will get the donor cells and red blood cell transfusions through the line. They will stay in the hospital about 30 days after the transfusion of donor cells. In first 3 months after the infusion, recipients will have many visits. Then they will have visits every 6 months to 1 year for 5 years. During those visits they will repeat some of the screening tests....
Trial Details
NCT Number NCT04008368
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Myeloid Chimerism
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov