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ACTIVE NOT RECRUITING Phase 2

Reduced Intensity Conditioning (RIC) Regimen for Patients With Non-malignant Disorders

NCT01050855 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase II pilot study to evaluate engraftment and toxicity of patients with non-malignant diseases using a reduced intensity conditioning regimen in the setting of allogeneic transplant for non malignant diseases. Bone Marrow or cord blood will be acceptable as a stem cell source. Recently, reduced intensity conditioning (RIC) regimens have been used for both adult patients with leukemias and pediatric patients with non-malignant diseases. These regimens are better tolerated, resulting in less transplant related morbidity and mortality. Stable mixed chimerism, while insufficient for eradication of leukemias, may be sufficient to cure patients with non-malignant diseases.

Interventions

  • DRUG RIC: Distal Campath
  • DRUG RIC:Intermediate Campath
  • DRUG RIC: Mini Busulfan

Study Locations (1)

Pennsylvania

  • The Children's Hospital of Philadelphia — Philadelphia

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2008-01
Est. Completion 2026-12
Phase Phase 2

Sponsor

Children's Hospital of Philadelphia

492 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01050855

The ClinicalTrials.gov registry entry for NCT01050855 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 492 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Hemoglobinopathies appearing as the primary indexed condition, and to 3 interventions — of which RIC: Distal Campath is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01050855 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01050855 about?

NCT01050855 is a clinical study titled "Reduced Intensity Conditioning (RIC) Regimen for Patients With Non-malignant Disorders". This is a Phase II pilot study to evaluate engraftment and toxicity of patients with non-malignant diseases using a reduced intensity conditioning regimen in the setting of allogeneic transplant for non malignant diseases. Bone Marrow or cord blood will be acceptable as a stem cell source. Recently...

What is the current status of trial NCT01050855?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2008-01. Estimated completion is 2026-12.

What conditions does trial NCT01050855 study?

This clinical trial studies the following conditions: Hemoglobinopathies, Immunodeficiencies, Non Malignant Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01050855?

The interventions under investigation include: RIC: Distal Campath (DRUG), RIC:Intermediate Campath (DRUG), RIC: Mini Busulfan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01050855?

This trial is sponsored by Children's Hospital of Philadelphia, which has 492 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01050855 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial