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NCT01626092 · ClinicalTrials.gov registry record · NA

Reduced-Intensity Hematopoietic Stem Cell Transplant for High Risk Lysosomal and Peroxisomal Disorders

A NA study, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
NA
Development phase
3
Enrollment target

NCT01626092: Completed NA study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT01626092 is a NA study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01626092, a NA study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
NA
Development phase
3 participants
Enrollment target

Study Summary

This study is designed to test the ability to achieve donor hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM) in patients with high-risk lysosomal and peroxisomal disorders using a novel conditioning regimen for hematopoietic cell transplantation (HCT). After a reduced-intensity conditioning regimen using volumetric-modulated arc therapy (VMAT)-delivered low-dose total body irradiation (TBI) with highly conformal marrow boosting, patients will be transplanted using either a related or unrelated allograft. The cell source may be marrow, peripheral blood or cord blood based on donor availability.

Primary Outcome

Number of patients who achieve hematopoietic engraftment - assessment of nucleated peripheral blood cells for donor (allogeneic) chimerism following this reduced-intensity HCT.

Interventions

  • DRUG Melphalan
  • DRUG Clofarabine
  • BIOLOGICAL Hematopoietic stem cell transplantation
  • DRUG Campath-1H
  • RADIATION Total Body Irradiation with Marrow Boosting

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2012-07-11
Est. Completion 2013-11
Phase NA

What the finished NCT01626092 record still lists

NCT01626092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

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

NCT01626092 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01626092 about?

NCT01626092 is a clinical study titled "Reduced-Intensity Hematopoietic Stem Cell Transplant for High Risk Lysosomal and Peroxisomal Disorders". This study is designed to test the ability to achieve donor hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM) in patients with high-risk lysosomal and peroxisomal disorders using a novel conditioning regimen for hematopoietic cell transplantation (HCT). Afte...

What is the current status of trial NCT01626092?

This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2012-07-11. Estimated completion is 2013-11.

What interventions are being tested in trial NCT01626092?

The interventions under investigation include: Melphalan (DRUG), Clofarabine (DRUG), Hematopoietic stem cell transplantation (BIOLOGICAL), Campath-1H (DRUG), Total Body Irradiation with Marrow Boosting (RADIATION).

Who is sponsoring clinical trial NCT01626092?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01626092's enrollment target sits among peer trials

3 1996th of 2000 higher than 4 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01626092, the US trial registry maintained by the National Library of Medicine. NCT01626092 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.