CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Granulocyte Colony Stimulating Factordrug
Likely dose
Granulocyte Colony Stimulating Factor (G-CSF) for bone marrow priming prior to harvest from donorAI-extracted
Key inclusion· 5
  • Patients with hematologic malignancies and non-malignancies who are candidates for matched sibling donor allogeneic bone marrow transplantation
  • Age under 55 years
  • Life expectancy of at least 12 weeks
  • Available histocompatible sibling donor who has been medically approved
Key exclusion· 6
  • Significant functional deficits in major organs that would interfere with successful transplant outcome
  • Evidence of active, deep-seated, life-threatening infections without known effective therapy (e.g., certain fungal species, HIV)
  • Hemoglobinopathy (sickle cell disease or thalassemia)
  • Greater than two leukemic episodes, active CNS/leukemic disease, or blast crisis in CML patients

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00231309
NCT00231309N/ACompleted

Pilot Study of Using Granulocyte Colony Stimulating Factor-Primed Bone Marrow in Histocompatible Sibling Allogeneic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies

Emory University·interventional·Posted Oct 4, 2005·Updated Aug 22, 2014

In Brief

A clinical study evaluating Granulocyte Colony Stimulating Factor for Hematologic Diseases and Hematologic Malignancies. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The major purpose of this study is to evaluate the curative potential of white cell growth hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants. Patients with cancers or blood diseases, who have poor potential for a cure with standard treatment, will be able to participate in the study. Donors will receive the white cell growth hormone (G-CSF) as a shot (injection) in their arm once a day for three days before they donate their bone marrow cells. Total body irradiation and/or chemotherapy will be given first to prepare the patient's body for the infusion of new bone marrow cells from the donor. Two medicines (cyclosporine and methotrexate) will be used to prevent the new bone marrow cells (graft) from attacking the patient's body (host) (graft-versus-host disease; GVHD). Certain safety checkpoints were built into the study if unwanted/unexpected events were to occur. If the outcomes appear better than could be expected, this will provide a bridge to extend this current approach for other innovative therapies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartJul 1, 2003
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.7 years ago

Interventions

Granulocyte Colony Stimulating Factordrug

Granulocyte Colony Stimulating Factor