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

NCT01050855 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-04

No results posted yet for this 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.

Conditions

  • Non Malignant Diseases
  • Immunodeficiencies
  • Hemoglobinopathies

Interventions

DRUG

RIC: Distal Campath

Campath, Fludarabine, Melphalan, Cyclosporine, Cellcept (MMF)

DRUG

RIC:Intermediate Campath

Campath, Fludarabine, Melphalan, Cyclosporine, Cellcept (MMF)

DRUG

RIC: Mini Busulfan

Campath, Fludarabine, Busulfan, Cyclosporine, Cellcept (MMF)

Sponsors & Collaborators

Principal Investigators

  • Timothy J Olson, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2024-07-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01050855 on ClinicalTrials.gov