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NCT00429143 · ClinicalTrials.gov registry record · Phase 1

A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative

A Phase 1 study of Hematologic Malignancies, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
1
Study location

NCT00429143 is a Phase 1 study of Hematologic Malignancies that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 27 participants, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00429143, a Phase 1 study of Hematologic Malignancies, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

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

Study Summary

The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to treat their disease. They will also receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will be exposed to one of the chemotherapy agents to help the patient become tolerant to the lymphocytes. In the second part of the transplant, the patient will receive their donor's stem cells to help recover their peripheral blood counts and establish long-term engraftment. The hypothesis of this study is that in partially-matched allogeneic transplant, there is a defined number of donor T-cells that can be treated and given to the recipient to avoid post-transplant infection without causing severe graft-versus-host disease.

Conditions Studied

Interventions

  • RADIATION Total Body Irradiation (TBI)
  • DRUG Tacrolimus
  • DRUG Mycophenolate Mofetil (MMF)
  • DRUG Cyclophosphamide (CY)
  • BIOLOGICAL Donor Lymphocyte Infusion (DLI)

Study Locations (1)

Pennsylvania

  • Thomas Jefferson University - Philadelphia

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2006-01
Est. Completion 2010-06
Phase Phase 1

What the Registry Record Tells You About NCT00429143

The ClinicalTrials.gov registry entry for NCT00429143 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hematologic Malignancies appearing as the primary indexed condition, and to 5 interventions - of which Total Body Irradiation (TBI) is the first listed.

NCT00429143 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00429143 about?

NCT00429143 is a clinical study titled "A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative". The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/...

What is the current status of trial NCT00429143?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2006-01. Estimated completion is 2010-06.

What conditions does trial NCT00429143 study?

This clinical trial studies the following conditions: Hematologic Malignancies.

What interventions are being tested in trial NCT00429143?

The interventions under investigation include: Total Body Irradiation (TBI) (RADIATION), Tacrolimus (DRUG), Mycophenolate Mofetil (MMF) (DRUG), Cyclophosphamide (CY) (DRUG), Donor Lymphocyte Infusion (DLI) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00429143?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00429143 being conducted?

This trial has 1 study location across Pennsylvania. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.