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NCT00489281 · ClinicalTrials.gov registry record · Phase 2

Non-Myeloablative Bone Marrow Transplant for Patients With Sickle Cell Anemia and Other Blood Disorders

A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Terminated
Registry status
Phase 2
Development phase
43
Enrollment target

NCT00489281: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT00489281 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00489281, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

TERMINATED
Registry status
Phase 2
Development phase
43 participants
Enrollment target

Study Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving sirolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by a donor bone marrow transplant works in treating patients with sickle cell anemia and other blood disorders.

Primary Outcome

Number of participants who died for reasons related to bone marrow transplant.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Sirolimus
  • DRUG Mycophenolate mofetil
  • PROCEDURE Allogeneic bone marrow transplant

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2008-06-23
Est. Completion 2018-12-29
Phase Phase 2

Why NCT00489281 stopped before completion

NCT00489281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00489281 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00489281 about?

NCT00489281 is a clinical study titled "Non-Myeloablative Bone Marrow Transplant for Patients With Sickle Cell Anemia and Other Blood Disorders". RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem...

What is the current status of trial NCT00489281?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2008-06-23. Estimated completion is 2018-12-29.

What interventions are being tested in trial NCT00489281?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Sirolimus (DRUG), Mycophenolate mofetil (DRUG), Allogeneic bone marrow transplant (PROCEDURE).

Who is sponsoring clinical trial NCT00489281?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00489281's enrollment target sits among peer trials

43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00489281, the US trial registry maintained by the National Library of Medicine. NCT00489281 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.