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NCT01244906 · ClinicalTrials.gov registry record · Phase 2

Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant

A Phase 2 study of Hematologic Neoplasms, sponsored by Northside Hospital.

Completed
Registry status
Phase 2
Development phase
26
Enrollment target
1
Study location

NCT01244906 is a Phase 2 study of Hematologic Neoplasms that has completed, run by Northside Hospital. The registered enrollment target is 26 participants, below the 1,025-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01244906, a Phase 2 study of Hematologic Neoplasms, has completed, sponsored by Northside Hospital.

COMPLETED
Registry status
Phase 2
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.

Conditions Studied

Interventions

  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

Study Locations (1)

Georgia

  • Northside Hospital - Atlanta

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2010-12
Est. Completion 2014-12
Phase Phase 2

Sponsor

Northside Hospital

26 total trials

What the Registry Record Tells You About NCT01244906

The ClinicalTrials.gov registry entry for NCT01244906 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,025-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (97% lower). The listed sponsor is Northside Hospital, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Allogeneic Hematopoietic Stem Cell Transplantation is the first listed.

NCT01244906 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT01244906 about?

NCT01244906 is a clinical study titled "Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant". This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GV...

What is the current status of trial NCT01244906?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-12. Estimated completion is 2014-12.

What conditions does trial NCT01244906 study?

This clinical trial studies the following conditions: Hematologic Neoplasms.

What interventions are being tested in trial NCT01244906?

The interventions under investigation include: Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT01244906?

This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01244906 being conducted?

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

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

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