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Improving the Results of Bone Marrow Transplantation for Patients With Severe Congenital Anemias

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 326 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion date: Jan 31, 2026 to Jan 20, 2028v326
  2. Results first posted: Feb 29, 2024v325 Show 8 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 130
    • Study completion date: Jan 20, 2024 to Jan 31, 2026
    • Interventions: Alemtuzumab (Drug), Peripheral blood hematopoietic progenitor cell (PBPC) transplant (Procedure), Peripheral blood hematopoietic progenitor… to Alemtuzumab (Drug), Peripheral blood hematopoietic progenitor cell (PBPC) transplant (Procedure), Peripheral blood hematopoietic progenitor…
    • Secondary endpoints revised (7)
    • Site details revised
    • Eligibility criteria shortened, about 2 words
  3. Re-verified, no change to tracked fieldsv324
  4. Primary completion date changed from estimate of Feb 1, 2024 to Jan 20, 2023
    • Study completion date: Feb 1, 2024 to Jan 20, 2024
    v323
  5. 10 versions Re-verified since Feb 18, 2023, no change to tracked fieldsv313-v322
Show 36 earlier versionsHide 36 earlier versions
  1. Primary completion date: Feb 1, 2023 to Feb 1, 2024v312
  2. 14 versions Re-verified since Nov 8, 2022, no change to tracked fieldsv298-v311
  3. Site contact updatedv297
  4. 6 versions Re-verified since Sep 8, 2022, no change to tracked fieldsv291-v296
  5. Study site revisedv290
  6. 13 versions Re-verified since Jun 23, 2022, no change to tracked fieldsv277-v289
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
People with severe congenital anemias, such as sickle cell anemia and beta-thalassemia, have been cured with bone marrow transplantation (BMT). The procedure, however, is limited to children younger than the age of 16 because the risks are lower for children than for adults. The purpose of this study is to explore the use of a BMT regimen that, instead of chemotherapy, uses a low dose of radiation, combined with two immunosuppressive drugs. This type BMT procedure is described as nonmyeloablative, meaning that it does not destroy the patient s bone marrow. It is hoped that this type of BMT will be safe for patients normally excluded from the procedure because of their age and other reasons. To participate in this study, patients must be between the ages of 18 and 65 and have a sibling who is a well-matched stem-cell donor. Beyond the standard BMT protocol, study participants will undergo additional procedures. The donor will receive G-CSF by injection for five days; then his or her stem cells will be collected and frozen one month prior to BMT. Approximately one month later, the patient will be given two immune-suppressing drugs, Campath 1-H and Sirolimus, as well as a single low dose of total body irradiation and then the cells from the donor will be infused. Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, breathing tests, heart-function tests, chest and sinus x-rays, and bone-marrow sampling.
Trial Details
NCT Number NCT00061568
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Congenital Hemolytic Anemia, Sickle Cell Disease
Related terms Anemia, Hemolytic, Congenital, Anemia, Sickle Cell, beta-Thalassemia
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov